2025 Q4 -tulosraportti
28 päivää sitten
‧32 min
Tarjoustasot
Nasdaq Copenhagen
Määrä
Osto
-
Myynti
Määrä
-
Viimeisimmät kaupat
| Aika | Hinta | Määrä | Ostaja | Myyjä |
|---|---|---|---|---|
| 300 | - | - | ||
| 27 934 | - | - | ||
| 1 691 | - | - | ||
| 6 710 | - | - | ||
| 790 | - | - |
Välittäjätilasto
Ostaneet eniten
| Välittäjä | Ostettu | Myyty | Netto | Sisäinen |
|---|---|---|---|---|
| Anonyymi | 121 971 | 121 971 | 0 | 0 |
Myyneet eniten
| Välittäjä | Ostettu | Myyty | Netto | Sisäinen |
|---|---|---|---|---|
| Anonyymi | 121 971 | 121 971 | 0 | 0 |
Yhtiötapahtumat
Datan lähde: FactSet, Quartr| Seuraava tapahtuma | |
|---|---|
2026 Q1 -tulosraportti 21.5. |
| Menneet tapahtumat | ||
|---|---|---|
2025 Q4 -tulosraportti 26.3. | ||
2025 Q3 -tulosraportti 19.11.2025 | ||
2025 Q2 -tulosraportti 15.8.2025 | ||
2025 Q1 -tulosraportti 8.5.2025 | ||
2024 Q4 -tulosraportti 20.3.2025 |
Asiakkaat katsoivat myös
Shareville
Liity keskusteluun SharevillessäShareville on aktiivisten yksityissijoittajien yhteisö, jossa voit seurata muiden asiakkaiden kaupankäyntiä ja omistuksia.
Kirjaudu
·21 t sitten · MuokattuKDIGO. When there has been a webcast and time for questions, one question is almost certain. Is there anything new about KDIGO? The answer every time, we have no knowledge of that. This question came up again at the last webcast. This time the answer was, we can expect it mid-2026. And it was emphasized that it was not certain that anything would come out about the NGAL test. I was not aware of what KDIGO was and why it was important for Bioporto. I have searched for answers online and am sharing it here. If you also don't know what KDIGO is? Why the recommendation from KDIGO is important for Bioporto, and would like to know, then read on. I have the following from the internet. First, what does KDIGO stand for? Answer: Kidney Disease: Improving Global Outcomes Who are they? They are an international non-profit organization that works to improve the care and outcomes for patients with kidney diseases worldwide. Their primary task is to develop and implement evidence-based clinical guidelines that doctors use to diagnose and treat kidney patients. It has been an independent institution since 2012. To get to the core of why it is important for Bioporto to get the NGAL test, recommendation from KDIGO, it is because if KDIGO recommends the NGAL test, it will be distributed to all hospitals worldwide. This will typically happen via the highly respected scientific magazine, Kidney international. This magazine is read by everyone in this industry. When KDIGO issues a recommendation, there will be different grades The best and most important one we should keep an eye on is: Recommendation or 1st degree. If the NGAL test receives this degree, it can be said briefly that Bioporto's NGAL test will become a blockbuster, and doctors will themselves contact Bioporto's collaboration partner to purchase the test. The next best is. Suggestion or 2nd degree. If the NGAL test receives this recommendation, it will mean progress for the NGAL test, but some groundwork will still be needed to sell the test. In my opinion, all other degrees are irrelevant for Bioporto, because the sales assistants will have to use the same resources to sell the test as before the publication. It turns out that in March 2026, it emerged in the aforementioned magazine that the new KDIGO AKI & AKD guidelines are setting the stage for a significant shift in the way kidney damage is diagnosed, and it is expected that the NGAL test will be mentioned here. It is expected that the consultation period will end on April 27, 2026. After that, some scientists will look at the figures that have been submitted to KDIGO. It is also expected that they will issue a recommendation in May-June 2026. But they are scientists, so they determine the deadline, so the recommendation could also come at another time. When KDIGO issues a recommendation, it will not state which tests they recommend, so as not to advertise for any companies. Only the NGAL test. The scientific procedure will be stated in the publication, and here, among other things, the company name. Bioporto, will be mentioned, because they have supplied their NGAL test for these scientific experiments, and it is mainly their test that has been used as a scientific basis. Plus, doctors in the industry have been following along and therefore know that Bioporto has supplied the NGAL test for this scientific experiment. So when there is a recommendation for the NGAL test, and preferably of the 1st degree ( wishful thinking ) Everyone who reads this recommendation will know that it is based on Bioporto's NGAL test. Therefore, it is very important for Bioporto that a recommendation finally comes, in fact, I would go so far as to say that it is Bioporto's fate that is at stake. For your information, it was in 2012 that the last recommendation for a kidney test was made. We can therefore expect that it will take at least as long before a new recommendation from the KDIGO organization will come. So in May-June, I will keep a close eye on the news to see if a recommendation comes and what degree they recommend (Once again, they are scientists, so the timing is not a fixed deadline) I hope I included the most important points.·1 t sitten · MuokattuThe following is what I have been able to find online. Like everything else with KDIGO, it's complicated. I have read that the people who are to assess, after the consultation period is over, are supposed to be very conservative and they don't throw around the two recommendations, as stated in the post above. Historically, with previous recommendations, there are some guidelines they can use to make a recommendation, but it's voluntary. I found five criteria, there may be more. I understand that we have to wait until the day their decision is announced for anything to be certain. Until then, it's a straw one clings to. Firstly. That there is evidence that the test works. Bioporto has FDA approval, and since FDA approval is considered the most difficult approval to get in the world. They will also include this approval as evidence, along with everything else. Secondly. That the test saves lives Bioporto has evidence that the test saves lives, because the test can detect problems already 2 hours after injury has occurred? Thirdly. That Hospitals can buy the test. It must not be so expensive that it breaks their budgets the price will be approved. Fourthly. That there is medicine for the disease/diseases that the test detects. There will be diseases that the test can detect and for which medicine exists, and there will possibly Be diseases that the test can detect for which no medicine exists, and here Bioporto will, with certainty, be able to argue its way out of this by demonstrating that scientists actually use their test to invent new medicine for these diseases for which there is currently no medicine. Fifthly. That the test can prevent permanent damage. Bioporto will also have evidence that it does. Bioporto's test meets all the above requirements, so there is a chance that the test leans towards the best recommendation, 1st degree. But are there more criteria? What is as certain as "amen in church" is that the consultation period ends on April 27. And until a recommendation comes, both management, the board, and large investors will stare in the direction of the KDIGO organization, perhaps not even blinking, to catch everything. Because if a 1st degree recommendation comes, Bioporto's test will become a Blockbuster, and all hospitals in the USA will rush to integrate the test into their treatment system to avoid lawsuits if one of their patients dies because they didn't have the test, and the rest of the world's hospitals will also need Bioporto's NGAL test. Furthermore, it will be the first time an NGAL test receives this recommendation. What CB and co. will be looking for is whether Paul Palevsky or Marlies Ostermann will comment to the aforementioned magazine or other recognized magazines. They might do that just before the final recommendation is published. I understand that they will not say anything directly, but might come up with some terms that a layman like me doesn't understand, but CB and co. do. What we need to look at is, what are the mentioned people at BP doing? Do they start buying BP shares wildly around the time of the final decision? If so, it might be because they have read something that Paul Palevsky or Marlies Ostermann have stated, which could suggest that the NGAL test will receive the best or the second-best recommendation? As I wrote above, we have to wait until the day their decision is announced for anything to be certain. Until then, it's a straw one clings to. The above is neither a buy nor a sell recommendation.- ·1 päivä sittenThere has been a seminar which you can read about by clicking on the link. https://www.linkedin.com/feed/update/urn:li:activity:7451975532352704514/
- ·3 päivää sittenOnly for those interested, everyone else ignore this post. I was curious about how it can be that Bioporto now uses the 510K application form for FDA approval for adults, and not de novo. What does it cost to get an approval from the FDA? The following is what I have found out. Bioporto uses 510K, and not de novo, because de novo is for products that are new to the market, and the test for adults is not. This time Bioporto must show that the test for adults works, and not as with the children's test, that they must have evidence that the test works. Since Bioporto is the originator of the children's test, which is used as a benchmark at the FDA, Bioporto must show that the test for adults is just as good as for children. Therefore, Bioporto's management states that the test for adults will be approved by 2027 at the latest, because the test for adults is compared with the test for children, which they themselves invented. The de novo application can only be obtained once, so this time it will cost Bioporto something to get an approval from the FDA. Because Bioporto is a smaller company, with revenue less than 100.000 $ per year, Bioporto gets a discount. Bioporto only has to pay approx. 41.000 kr, instead of the full amount approx. 165.100 kr. This is the explanation I could find for how it can be that Bioporto has announced that they expect the adult test to be FDA approved by 2027 at the latest. After they have sold the antibodies, they have also announced that they do not expect any issuance, which they can, because the process for approval for adults will be much cheaper than when the test for children had to be approved.·1 päivä sittenThe crucial thing must be that the test is approved, and in that context, I think it must be of less importance whether it is via de Novo or 510K. I don't know if that's the right word to use, but let it pass, I think the FDA can probably use the children's version as a benchmark in connection with the approval. The most crucial thing, however, must be the future/expected sales, and in that respect, it should probably be just as or actually more relevant again to use the children's version as a benchmark for the adult version, and that doesn't make me particularly optimistic? If hospitals can't see a point in using ngal for treating children, why should they see a point in using ngal for adults?
·15.4.Following my post on 8. March, management's shareholdings in BioPorto are a strong optimistic signal, as stated in Carnegie's report page 48. Among the company's ten largest shareholders are CEO, CLO, former CEO, chairman and vice charirman. The ten largest shareholders hold approx. 33%. Since Martin Bundgaard first flagged his 5% on Monday, they are not included in Carnegie's overview. From my post on 8. March: 2026 could be a very good year for BioPorto: The sentiment for biotech on Wall Street has turned significantly at the beginning of 2026, and the IPO market (initial public offerings) shows clear signs of life after several years of dormancy. After a very quiet 2024 and a historically weak 2025, investors have returned with renewed optimism. The Chairman, Jens Due Olsen, has invested approx. 6 million kr. of his own funds in 2025 (at prices 1.34 and 1.07 in the two emissions). Remarkable for a company of BioPorto's size. * Signal: Chairmen in biotech companies rarely make million-dollar investments shortly before crucial clinical data, unless they have a very strong belief in the company's fundamental value and the preliminary observations from the studies. * Risk/Reward: He bought in at a time when the stock is close to its historical low, which suggests that he sees a significant asymmetric gain opportunity when the adult data is expected to land later in 2026 Carsten Buhl joined on 1. September 2025, as the new CEO, and already in November chose to invest approx. 500,000 kr. in the emission. * Insight: As CEO, he has direct responsibility for the execution of the clinical study for adults. His willingness to invest his own money so quickly after his employment is interpreted as him "liking what he sees" in the internal processes and in the dialogue with the American clinics.- ·15.4.
Yllä olevat kommentit ovat peräisin Nordnetin sosiaalisen verkoston Sharevillen käyttäjiltä, eikä niitä ole muokattu eikä Nordnet ole tarkastanut niitä etukäteen. Ne eivät tarkoita, että Nordnet tarjoaisi sijoitusneuvoja tai sijoitussuosituksia. Nordnet ei ota vastuuta kommenteista.
Uutiset
Tämän sivun uutiset ja/tai sijoitussuositukset tai otteet niistä sekä niihin liittyvät linkit ovat mainitun tahon tuottamia ja toimittamia. Nordnet ei ole osallistunut materiaalin laatimiseen, eikä ole tarkistanut sen sisältöä tai tehnyt sisältöön muutoksia. Lue lisää sijoitussuosituksista.
2025 Q4 -tulosraportti
28 päivää sitten
‧32 min
Uutiset
Tämän sivun uutiset ja/tai sijoitussuositukset tai otteet niistä sekä niihin liittyvät linkit ovat mainitun tahon tuottamia ja toimittamia. Nordnet ei ole osallistunut materiaalin laatimiseen, eikä ole tarkistanut sen sisältöä tai tehnyt sisältöön muutoksia. Lue lisää sijoitussuosituksista.
Shareville
Liity keskusteluun SharevillessäShareville on aktiivisten yksityissijoittajien yhteisö, jossa voit seurata muiden asiakkaiden kaupankäyntiä ja omistuksia.
Kirjaudu
- ·21 t sitten · MuokattuKDIGO. When there has been a webcast and time for questions, one question is almost certain. Is there anything new about KDIGO? The answer every time, we have no knowledge of that. This question came up again at the last webcast. This time the answer was, we can expect it mid-2026. And it was emphasized that it was not certain that anything would come out about the NGAL test. I was not aware of what KDIGO was and why it was important for Bioporto. I have searched for answers online and am sharing it here. If you also don't know what KDIGO is? Why the recommendation from KDIGO is important for Bioporto, and would like to know, then read on. I have the following from the internet. First, what does KDIGO stand for? Answer: Kidney Disease: Improving Global Outcomes Who are they? They are an international non-profit organization that works to improve the care and outcomes for patients with kidney diseases worldwide. Their primary task is to develop and implement evidence-based clinical guidelines that doctors use to diagnose and treat kidney patients. It has been an independent institution since 2012. To get to the core of why it is important for Bioporto to get the NGAL test, recommendation from KDIGO, it is because if KDIGO recommends the NGAL test, it will be distributed to all hospitals worldwide. This will typically happen via the highly respected scientific magazine, Kidney international. This magazine is read by everyone in this industry. When KDIGO issues a recommendation, there will be different grades The best and most important one we should keep an eye on is: Recommendation or 1st degree. If the NGAL test receives this degree, it can be said briefly that Bioporto's NGAL test will become a blockbuster, and doctors will themselves contact Bioporto's collaboration partner to purchase the test. The next best is. Suggestion or 2nd degree. If the NGAL test receives this recommendation, it will mean progress for the NGAL test, but some groundwork will still be needed to sell the test. In my opinion, all other degrees are irrelevant for Bioporto, because the sales assistants will have to use the same resources to sell the test as before the publication. It turns out that in March 2026, it emerged in the aforementioned magazine that the new KDIGO AKI & AKD guidelines are setting the stage for a significant shift in the way kidney damage is diagnosed, and it is expected that the NGAL test will be mentioned here. It is expected that the consultation period will end on April 27, 2026. After that, some scientists will look at the figures that have been submitted to KDIGO. It is also expected that they will issue a recommendation in May-June 2026. But they are scientists, so they determine the deadline, so the recommendation could also come at another time. When KDIGO issues a recommendation, it will not state which tests they recommend, so as not to advertise for any companies. Only the NGAL test. The scientific procedure will be stated in the publication, and here, among other things, the company name. Bioporto, will be mentioned, because they have supplied their NGAL test for these scientific experiments, and it is mainly their test that has been used as a scientific basis. Plus, doctors in the industry have been following along and therefore know that Bioporto has supplied the NGAL test for this scientific experiment. So when there is a recommendation for the NGAL test, and preferably of the 1st degree ( wishful thinking ) Everyone who reads this recommendation will know that it is based on Bioporto's NGAL test. Therefore, it is very important for Bioporto that a recommendation finally comes, in fact, I would go so far as to say that it is Bioporto's fate that is at stake. For your information, it was in 2012 that the last recommendation for a kidney test was made. We can therefore expect that it will take at least as long before a new recommendation from the KDIGO organization will come. So in May-June, I will keep a close eye on the news to see if a recommendation comes and what degree they recommend (Once again, they are scientists, so the timing is not a fixed deadline) I hope I included the most important points.·1 t sitten · MuokattuThe following is what I have been able to find online. Like everything else with KDIGO, it's complicated. I have read that the people who are to assess, after the consultation period is over, are supposed to be very conservative and they don't throw around the two recommendations, as stated in the post above. Historically, with previous recommendations, there are some guidelines they can use to make a recommendation, but it's voluntary. I found five criteria, there may be more. I understand that we have to wait until the day their decision is announced for anything to be certain. Until then, it's a straw one clings to. Firstly. That there is evidence that the test works. Bioporto has FDA approval, and since FDA approval is considered the most difficult approval to get in the world. They will also include this approval as evidence, along with everything else. Secondly. That the test saves lives Bioporto has evidence that the test saves lives, because the test can detect problems already 2 hours after injury has occurred? Thirdly. That Hospitals can buy the test. It must not be so expensive that it breaks their budgets the price will be approved. Fourthly. That there is medicine for the disease/diseases that the test detects. There will be diseases that the test can detect and for which medicine exists, and there will possibly Be diseases that the test can detect for which no medicine exists, and here Bioporto will, with certainty, be able to argue its way out of this by demonstrating that scientists actually use their test to invent new medicine for these diseases for which there is currently no medicine. Fifthly. That the test can prevent permanent damage. Bioporto will also have evidence that it does. Bioporto's test meets all the above requirements, so there is a chance that the test leans towards the best recommendation, 1st degree. But are there more criteria? What is as certain as "amen in church" is that the consultation period ends on April 27. And until a recommendation comes, both management, the board, and large investors will stare in the direction of the KDIGO organization, perhaps not even blinking, to catch everything. Because if a 1st degree recommendation comes, Bioporto's test will become a Blockbuster, and all hospitals in the USA will rush to integrate the test into their treatment system to avoid lawsuits if one of their patients dies because they didn't have the test, and the rest of the world's hospitals will also need Bioporto's NGAL test. Furthermore, it will be the first time an NGAL test receives this recommendation. What CB and co. will be looking for is whether Paul Palevsky or Marlies Ostermann will comment to the aforementioned magazine or other recognized magazines. They might do that just before the final recommendation is published. I understand that they will not say anything directly, but might come up with some terms that a layman like me doesn't understand, but CB and co. do. What we need to look at is, what are the mentioned people at BP doing? Do they start buying BP shares wildly around the time of the final decision? If so, it might be because they have read something that Paul Palevsky or Marlies Ostermann have stated, which could suggest that the NGAL test will receive the best or the second-best recommendation? As I wrote above, we have to wait until the day their decision is announced for anything to be certain. Until then, it's a straw one clings to. The above is neither a buy nor a sell recommendation.
- ·1 päivä sittenThere has been a seminar which you can read about by clicking on the link. https://www.linkedin.com/feed/update/urn:li:activity:7451975532352704514/
- ·3 päivää sittenOnly for those interested, everyone else ignore this post. I was curious about how it can be that Bioporto now uses the 510K application form for FDA approval for adults, and not de novo. What does it cost to get an approval from the FDA? The following is what I have found out. Bioporto uses 510K, and not de novo, because de novo is for products that are new to the market, and the test for adults is not. This time Bioporto must show that the test for adults works, and not as with the children's test, that they must have evidence that the test works. Since Bioporto is the originator of the children's test, which is used as a benchmark at the FDA, Bioporto must show that the test for adults is just as good as for children. Therefore, Bioporto's management states that the test for adults will be approved by 2027 at the latest, because the test for adults is compared with the test for children, which they themselves invented. The de novo application can only be obtained once, so this time it will cost Bioporto something to get an approval from the FDA. Because Bioporto is a smaller company, with revenue less than 100.000 $ per year, Bioporto gets a discount. Bioporto only has to pay approx. 41.000 kr, instead of the full amount approx. 165.100 kr. This is the explanation I could find for how it can be that Bioporto has announced that they expect the adult test to be FDA approved by 2027 at the latest. After they have sold the antibodies, they have also announced that they do not expect any issuance, which they can, because the process for approval for adults will be much cheaper than when the test for children had to be approved.·1 päivä sittenThe crucial thing must be that the test is approved, and in that context, I think it must be of less importance whether it is via de Novo or 510K. I don't know if that's the right word to use, but let it pass, I think the FDA can probably use the children's version as a benchmark in connection with the approval. The most crucial thing, however, must be the future/expected sales, and in that respect, it should probably be just as or actually more relevant again to use the children's version as a benchmark for the adult version, and that doesn't make me particularly optimistic? If hospitals can't see a point in using ngal for treating children, why should they see a point in using ngal for adults?
- ·15.4.Following my post on 8. March, management's shareholdings in BioPorto are a strong optimistic signal, as stated in Carnegie's report page 48. Among the company's ten largest shareholders are CEO, CLO, former CEO, chairman and vice charirman. The ten largest shareholders hold approx. 33%. Since Martin Bundgaard first flagged his 5% on Monday, they are not included in Carnegie's overview. From my post on 8. March: 2026 could be a very good year for BioPorto: The sentiment for biotech on Wall Street has turned significantly at the beginning of 2026, and the IPO market (initial public offerings) shows clear signs of life after several years of dormancy. After a very quiet 2024 and a historically weak 2025, investors have returned with renewed optimism. The Chairman, Jens Due Olsen, has invested approx. 6 million kr. of his own funds in 2025 (at prices 1.34 and 1.07 in the two emissions). Remarkable for a company of BioPorto's size. * Signal: Chairmen in biotech companies rarely make million-dollar investments shortly before crucial clinical data, unless they have a very strong belief in the company's fundamental value and the preliminary observations from the studies. * Risk/Reward: He bought in at a time when the stock is close to its historical low, which suggests that he sees a significant asymmetric gain opportunity when the adult data is expected to land later in 2026 Carsten Buhl joined on 1. September 2025, as the new CEO, and already in November chose to invest approx. 500,000 kr. in the emission. * Insight: As CEO, he has direct responsibility for the execution of the clinical study for adults. His willingness to invest his own money so quickly after his employment is interpreted as him "liking what he sees" in the internal processes and in the dialogue with the American clinics.
- ·15.4.
Yllä olevat kommentit ovat peräisin Nordnetin sosiaalisen verkoston Sharevillen käyttäjiltä, eikä niitä ole muokattu eikä Nordnet ole tarkastanut niitä etukäteen. Ne eivät tarkoita, että Nordnet tarjoaisi sijoitusneuvoja tai sijoitussuosituksia. Nordnet ei ota vastuuta kommenteista.
Tarjoustasot
Nasdaq Copenhagen
Määrä
Osto
-
Myynti
Määrä
-
Viimeisimmät kaupat
| Aika | Hinta | Määrä | Ostaja | Myyjä |
|---|---|---|---|---|
| 300 | - | - | ||
| 27 934 | - | - | ||
| 1 691 | - | - | ||
| 6 710 | - | - | ||
| 790 | - | - |
Välittäjätilasto
Ostaneet eniten
| Välittäjä | Ostettu | Myyty | Netto | Sisäinen |
|---|---|---|---|---|
| Anonyymi | 121 971 | 121 971 | 0 | 0 |
Myyneet eniten
| Välittäjä | Ostettu | Myyty | Netto | Sisäinen |
|---|---|---|---|---|
| Anonyymi | 121 971 | 121 971 | 0 | 0 |
Asiakkaat katsoivat myös
Yhtiötapahtumat
Datan lähde: FactSet, Quartr| Seuraava tapahtuma | |
|---|---|
2026 Q1 -tulosraportti 21.5. |
| Menneet tapahtumat | ||
|---|---|---|
2025 Q4 -tulosraportti 26.3. | ||
2025 Q3 -tulosraportti 19.11.2025 | ||
2025 Q2 -tulosraportti 15.8.2025 | ||
2025 Q1 -tulosraportti 8.5.2025 | ||
2024 Q4 -tulosraportti 20.3.2025 |
2025 Q4 -tulosraportti
28 päivää sitten
‧32 min
Uutiset
Tämän sivun uutiset ja/tai sijoitussuositukset tai otteet niistä sekä niihin liittyvät linkit ovat mainitun tahon tuottamia ja toimittamia. Nordnet ei ole osallistunut materiaalin laatimiseen, eikä ole tarkistanut sen sisältöä tai tehnyt sisältöön muutoksia. Lue lisää sijoitussuosituksista.
Yhtiötapahtumat
Datan lähde: FactSet, Quartr| Seuraava tapahtuma | |
|---|---|
2026 Q1 -tulosraportti 21.5. |
| Menneet tapahtumat | ||
|---|---|---|
2025 Q4 -tulosraportti 26.3. | ||
2025 Q3 -tulosraportti 19.11.2025 | ||
2025 Q2 -tulosraportti 15.8.2025 | ||
2025 Q1 -tulosraportti 8.5.2025 | ||
2024 Q4 -tulosraportti 20.3.2025 |
Shareville
Liity keskusteluun SharevillessäShareville on aktiivisten yksityissijoittajien yhteisö, jossa voit seurata muiden asiakkaiden kaupankäyntiä ja omistuksia.
Kirjaudu
- ·21 t sitten · MuokattuKDIGO. When there has been a webcast and time for questions, one question is almost certain. Is there anything new about KDIGO? The answer every time, we have no knowledge of that. This question came up again at the last webcast. This time the answer was, we can expect it mid-2026. And it was emphasized that it was not certain that anything would come out about the NGAL test. I was not aware of what KDIGO was and why it was important for Bioporto. I have searched for answers online and am sharing it here. If you also don't know what KDIGO is? Why the recommendation from KDIGO is important for Bioporto, and would like to know, then read on. I have the following from the internet. First, what does KDIGO stand for? Answer: Kidney Disease: Improving Global Outcomes Who are they? They are an international non-profit organization that works to improve the care and outcomes for patients with kidney diseases worldwide. Their primary task is to develop and implement evidence-based clinical guidelines that doctors use to diagnose and treat kidney patients. It has been an independent institution since 2012. To get to the core of why it is important for Bioporto to get the NGAL test, recommendation from KDIGO, it is because if KDIGO recommends the NGAL test, it will be distributed to all hospitals worldwide. This will typically happen via the highly respected scientific magazine, Kidney international. This magazine is read by everyone in this industry. When KDIGO issues a recommendation, there will be different grades The best and most important one we should keep an eye on is: Recommendation or 1st degree. If the NGAL test receives this degree, it can be said briefly that Bioporto's NGAL test will become a blockbuster, and doctors will themselves contact Bioporto's collaboration partner to purchase the test. The next best is. Suggestion or 2nd degree. If the NGAL test receives this recommendation, it will mean progress for the NGAL test, but some groundwork will still be needed to sell the test. In my opinion, all other degrees are irrelevant for Bioporto, because the sales assistants will have to use the same resources to sell the test as before the publication. It turns out that in March 2026, it emerged in the aforementioned magazine that the new KDIGO AKI & AKD guidelines are setting the stage for a significant shift in the way kidney damage is diagnosed, and it is expected that the NGAL test will be mentioned here. It is expected that the consultation period will end on April 27, 2026. After that, some scientists will look at the figures that have been submitted to KDIGO. It is also expected that they will issue a recommendation in May-June 2026. But they are scientists, so they determine the deadline, so the recommendation could also come at another time. When KDIGO issues a recommendation, it will not state which tests they recommend, so as not to advertise for any companies. Only the NGAL test. The scientific procedure will be stated in the publication, and here, among other things, the company name. Bioporto, will be mentioned, because they have supplied their NGAL test for these scientific experiments, and it is mainly their test that has been used as a scientific basis. Plus, doctors in the industry have been following along and therefore know that Bioporto has supplied the NGAL test for this scientific experiment. So when there is a recommendation for the NGAL test, and preferably of the 1st degree ( wishful thinking ) Everyone who reads this recommendation will know that it is based on Bioporto's NGAL test. Therefore, it is very important for Bioporto that a recommendation finally comes, in fact, I would go so far as to say that it is Bioporto's fate that is at stake. For your information, it was in 2012 that the last recommendation for a kidney test was made. We can therefore expect that it will take at least as long before a new recommendation from the KDIGO organization will come. So in May-June, I will keep a close eye on the news to see if a recommendation comes and what degree they recommend (Once again, they are scientists, so the timing is not a fixed deadline) I hope I included the most important points.·1 t sitten · MuokattuThe following is what I have been able to find online. Like everything else with KDIGO, it's complicated. I have read that the people who are to assess, after the consultation period is over, are supposed to be very conservative and they don't throw around the two recommendations, as stated in the post above. Historically, with previous recommendations, there are some guidelines they can use to make a recommendation, but it's voluntary. I found five criteria, there may be more. I understand that we have to wait until the day their decision is announced for anything to be certain. Until then, it's a straw one clings to. Firstly. That there is evidence that the test works. Bioporto has FDA approval, and since FDA approval is considered the most difficult approval to get in the world. They will also include this approval as evidence, along with everything else. Secondly. That the test saves lives Bioporto has evidence that the test saves lives, because the test can detect problems already 2 hours after injury has occurred? Thirdly. That Hospitals can buy the test. It must not be so expensive that it breaks their budgets the price will be approved. Fourthly. That there is medicine for the disease/diseases that the test detects. There will be diseases that the test can detect and for which medicine exists, and there will possibly Be diseases that the test can detect for which no medicine exists, and here Bioporto will, with certainty, be able to argue its way out of this by demonstrating that scientists actually use their test to invent new medicine for these diseases for which there is currently no medicine. Fifthly. That the test can prevent permanent damage. Bioporto will also have evidence that it does. Bioporto's test meets all the above requirements, so there is a chance that the test leans towards the best recommendation, 1st degree. But are there more criteria? What is as certain as "amen in church" is that the consultation period ends on April 27. And until a recommendation comes, both management, the board, and large investors will stare in the direction of the KDIGO organization, perhaps not even blinking, to catch everything. Because if a 1st degree recommendation comes, Bioporto's test will become a Blockbuster, and all hospitals in the USA will rush to integrate the test into their treatment system to avoid lawsuits if one of their patients dies because they didn't have the test, and the rest of the world's hospitals will also need Bioporto's NGAL test. Furthermore, it will be the first time an NGAL test receives this recommendation. What CB and co. will be looking for is whether Paul Palevsky or Marlies Ostermann will comment to the aforementioned magazine or other recognized magazines. They might do that just before the final recommendation is published. I understand that they will not say anything directly, but might come up with some terms that a layman like me doesn't understand, but CB and co. do. What we need to look at is, what are the mentioned people at BP doing? Do they start buying BP shares wildly around the time of the final decision? If so, it might be because they have read something that Paul Palevsky or Marlies Ostermann have stated, which could suggest that the NGAL test will receive the best or the second-best recommendation? As I wrote above, we have to wait until the day their decision is announced for anything to be certain. Until then, it's a straw one clings to. The above is neither a buy nor a sell recommendation.
- ·1 päivä sittenThere has been a seminar which you can read about by clicking on the link. https://www.linkedin.com/feed/update/urn:li:activity:7451975532352704514/
- ·3 päivää sittenOnly for those interested, everyone else ignore this post. I was curious about how it can be that Bioporto now uses the 510K application form for FDA approval for adults, and not de novo. What does it cost to get an approval from the FDA? The following is what I have found out. Bioporto uses 510K, and not de novo, because de novo is for products that are new to the market, and the test for adults is not. This time Bioporto must show that the test for adults works, and not as with the children's test, that they must have evidence that the test works. Since Bioporto is the originator of the children's test, which is used as a benchmark at the FDA, Bioporto must show that the test for adults is just as good as for children. Therefore, Bioporto's management states that the test for adults will be approved by 2027 at the latest, because the test for adults is compared with the test for children, which they themselves invented. The de novo application can only be obtained once, so this time it will cost Bioporto something to get an approval from the FDA. Because Bioporto is a smaller company, with revenue less than 100.000 $ per year, Bioporto gets a discount. Bioporto only has to pay approx. 41.000 kr, instead of the full amount approx. 165.100 kr. This is the explanation I could find for how it can be that Bioporto has announced that they expect the adult test to be FDA approved by 2027 at the latest. After they have sold the antibodies, they have also announced that they do not expect any issuance, which they can, because the process for approval for adults will be much cheaper than when the test for children had to be approved.·1 päivä sittenThe crucial thing must be that the test is approved, and in that context, I think it must be of less importance whether it is via de Novo or 510K. I don't know if that's the right word to use, but let it pass, I think the FDA can probably use the children's version as a benchmark in connection with the approval. The most crucial thing, however, must be the future/expected sales, and in that respect, it should probably be just as or actually more relevant again to use the children's version as a benchmark for the adult version, and that doesn't make me particularly optimistic? If hospitals can't see a point in using ngal for treating children, why should they see a point in using ngal for adults?
- ·15.4.Following my post on 8. March, management's shareholdings in BioPorto are a strong optimistic signal, as stated in Carnegie's report page 48. Among the company's ten largest shareholders are CEO, CLO, former CEO, chairman and vice charirman. The ten largest shareholders hold approx. 33%. Since Martin Bundgaard first flagged his 5% on Monday, they are not included in Carnegie's overview. From my post on 8. March: 2026 could be a very good year for BioPorto: The sentiment for biotech on Wall Street has turned significantly at the beginning of 2026, and the IPO market (initial public offerings) shows clear signs of life after several years of dormancy. After a very quiet 2024 and a historically weak 2025, investors have returned with renewed optimism. The Chairman, Jens Due Olsen, has invested approx. 6 million kr. of his own funds in 2025 (at prices 1.34 and 1.07 in the two emissions). Remarkable for a company of BioPorto's size. * Signal: Chairmen in biotech companies rarely make million-dollar investments shortly before crucial clinical data, unless they have a very strong belief in the company's fundamental value and the preliminary observations from the studies. * Risk/Reward: He bought in at a time when the stock is close to its historical low, which suggests that he sees a significant asymmetric gain opportunity when the adult data is expected to land later in 2026 Carsten Buhl joined on 1. September 2025, as the new CEO, and already in November chose to invest approx. 500,000 kr. in the emission. * Insight: As CEO, he has direct responsibility for the execution of the clinical study for adults. His willingness to invest his own money so quickly after his employment is interpreted as him "liking what he sees" in the internal processes and in the dialogue with the American clinics.
- ·15.4.
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