2026 Q1 -tulosraportti
Vain PDF
91 päivää sitten
Tarjoustasot
Ei dataa
Viimeisimmät kaupat
| Aika | Hinta | Määrä | Ostaja | Myyjä |
|---|---|---|---|---|
| - | - | - | - |
Huomioi, että vaikka osakkeisiin säästäminen on pitkällä aikavälillä tuottanut hyvin, tulevasta tuotosta ei ole takeita. On olemassa riski, että et saa sijoittamiasi varoja takaisin.
Välittäjätilasto
Dataa ei löytynyt
Yhtiötapahtumat
Datan lähde: FactSet, Quartr| Seuraava tapahtuma | |
|---|---|
2026 Q2 -tulosraportti 5.8. |
| Menneet tapahtumat | ||
|---|---|---|
2026 Q1 -tulosraportti 28.4. | ||
2025 Q4 -tulosraportti 12.2. | ||
2025 Q3 -tulosraportti 5.11.2025 | ||
2025 Q2 -tulosraportti 15.8.2025 | ||
2025 Q1 -tulosraportti 7.5.2025 |
Asiakkaat katsoivat myös
Foorumi
Liity keskusteluun Nordnet Socialissa
Kirjaudu
·10.7.Another lovely summer day to be 55% down on :)
·3.7.Short-term, this is a gamble, with very great potential, one wonders what the market thinks, is one burned by previous setbacks or does one see an approval in the near future? Long-term, this will go well is my thought.
Nilopki has received a rejection once (June 2026). Dasynoc has received a rejection once before (October 2025) and is now in its second review round with the FDA, with a PDUFA date in August. So, third time's the charm 😅- ·26.6.Are the machines in order now so there won't be impurities and stains in the manufacturing process. Have they test-run them properly?
·26.6.I see this as good opportunities, wise to arrange a meeting so that one kind of collaborates with FDA in a constructive way, which should speed up the process. 👌👍Asked AI what it's worth now, (anyway, an approval will come sooner or later) We owners have been severely tested so far, but surely we see the goal now! Question: Given previous experience with the timeline, will FDA manage to conduct an inspection and document it before PDUFA August 25, 2026? Answer: Yes, time-wise it is entirely possible for FDA to manage both inspection and documentation before the PDUFA date of August 25, 2026, but the time margin is extremely tight. Based on experience and historically, there are three critical factors and precedents that determine if they succeed in hitting this window of approximately two months: 1. FDA's standardized lead times Inspection length: A foreign routine or Pre-Approval Inspection (PAI) on-site at a contract manufacturer like NerPharMa usually takes 5 to 10 business days. Documentation (Form 483): If inspectors find deficiencies, a so-called Form 483 protocol is issued directly on the last day of the inspection. The company then has 15 business days to respond. Final Report (EIR): If the inspection is completely clean (or "VAI" – Voluntary Action Indicated), FDA writes its internal final report (Establishment Inspection Report) within 30 to 45 days. 2. Mutual Recognition (MRA) accelerates the process The absolute biggest time-saving factor in this case is that NerPharMa is located in Italy. The USA and EU have a Mutual Recognition Agreement (MRA). Since the Italian Medicines Agency (AIFA) has just completed a successful inspection of the facility, FDA can theoretically choose to: Waive the manufacturing risk based on AIFA's documentation. Conduct a significantly shortened or entirely focused desk inspection (Remote Regulatory Assessment) instead of sending personnel physically from the USA, which saves weeks in logistics. 3. Risk of PDUFA extension (Major Amendment) If FDA chooses to conduct a physical on-site inspection in Italy during July/August, and requires Xspray or NerPharMa to submit significant amounts of new data in response to the inspection, this is often classified as a "Major Amendment". Given previous experience with FDA's regulations, the agency then automatically moves the PDUFA date forward by 3 months to give its reviewers time to go through the new data. Conclusion The review of Dasynoc is already in its final phase with ongoing labeling, which shows that FDA is actively working in the system to reach the goal in August. Thanks to the recent AIFA inspection, FDA has the necessary documentation to act quickly. However, if a physical inspection is required, it must be scheduled and carried out in the coming weeks of July for the timeline to hold without being postponed until late autumn 2026.
Yllä olevat kommentit ovat peräisin Nordnetin sosiaalisen verkoston Nordnet Socialin 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.
2026 Q1 -tulosraportti
Vain PDF
91 päivää sitten
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.
Foorumi
Liity keskusteluun Nordnet Socialissa
Kirjaudu
- ·10.7.Another lovely summer day to be 55% down on :)
- ·3.7.Short-term, this is a gamble, with very great potential, one wonders what the market thinks, is one burned by previous setbacks or does one see an approval in the near future? Long-term, this will go well is my thought.Nilopki has received a rejection once (June 2026). Dasynoc has received a rejection once before (October 2025) and is now in its second review round with the FDA, with a PDUFA date in August. So, third time's the charm 😅
- ·26.6.Are the machines in order now so there won't be impurities and stains in the manufacturing process. Have they test-run them properly?
- ·26.6.I see this as good opportunities, wise to arrange a meeting so that one kind of collaborates with FDA in a constructive way, which should speed up the process. 👌👍Asked AI what it's worth now, (anyway, an approval will come sooner or later) We owners have been severely tested so far, but surely we see the goal now! Question: Given previous experience with the timeline, will FDA manage to conduct an inspection and document it before PDUFA August 25, 2026? Answer: Yes, time-wise it is entirely possible for FDA to manage both inspection and documentation before the PDUFA date of August 25, 2026, but the time margin is extremely tight. Based on experience and historically, there are three critical factors and precedents that determine if they succeed in hitting this window of approximately two months: 1. FDA's standardized lead times Inspection length: A foreign routine or Pre-Approval Inspection (PAI) on-site at a contract manufacturer like NerPharMa usually takes 5 to 10 business days. Documentation (Form 483): If inspectors find deficiencies, a so-called Form 483 protocol is issued directly on the last day of the inspection. The company then has 15 business days to respond. Final Report (EIR): If the inspection is completely clean (or "VAI" – Voluntary Action Indicated), FDA writes its internal final report (Establishment Inspection Report) within 30 to 45 days. 2. Mutual Recognition (MRA) accelerates the process The absolute biggest time-saving factor in this case is that NerPharMa is located in Italy. The USA and EU have a Mutual Recognition Agreement (MRA). Since the Italian Medicines Agency (AIFA) has just completed a successful inspection of the facility, FDA can theoretically choose to: Waive the manufacturing risk based on AIFA's documentation. Conduct a significantly shortened or entirely focused desk inspection (Remote Regulatory Assessment) instead of sending personnel physically from the USA, which saves weeks in logistics. 3. Risk of PDUFA extension (Major Amendment) If FDA chooses to conduct a physical on-site inspection in Italy during July/August, and requires Xspray or NerPharMa to submit significant amounts of new data in response to the inspection, this is often classified as a "Major Amendment". Given previous experience with FDA's regulations, the agency then automatically moves the PDUFA date forward by 3 months to give its reviewers time to go through the new data. Conclusion The review of Dasynoc is already in its final phase with ongoing labeling, which shows that FDA is actively working in the system to reach the goal in August. Thanks to the recent AIFA inspection, FDA has the necessary documentation to act quickly. However, if a physical inspection is required, it must be scheduled and carried out in the coming weeks of July for the timeline to hold without being postponed until late autumn 2026.
Yllä olevat kommentit ovat peräisin Nordnetin sosiaalisen verkoston Nordnet Socialin 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
Ei dataa
Viimeisimmät kaupat
| Aika | Hinta | Määrä | Ostaja | Myyjä |
|---|---|---|---|---|
| - | - | - | - |
Huomioi, että vaikka osakkeisiin säästäminen on pitkällä aikavälillä tuottanut hyvin, tulevasta tuotosta ei ole takeita. On olemassa riski, että et saa sijoittamiasi varoja takaisin.
Välittäjätilasto
Dataa ei löytynyt
Asiakkaat katsoivat myös
Yhtiötapahtumat
Datan lähde: FactSet, Quartr| Seuraava tapahtuma | |
|---|---|
2026 Q2 -tulosraportti 5.8. |
| Menneet tapahtumat | ||
|---|---|---|
2026 Q1 -tulosraportti 28.4. | ||
2025 Q4 -tulosraportti 12.2. | ||
2025 Q3 -tulosraportti 5.11.2025 | ||
2025 Q2 -tulosraportti 15.8.2025 | ||
2025 Q1 -tulosraportti 7.5.2025 |
2026 Q1 -tulosraportti
Vain PDF
91 päivää sitten
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 Q2 -tulosraportti 5.8. |
| Menneet tapahtumat | ||
|---|---|---|
2026 Q1 -tulosraportti 28.4. | ||
2025 Q4 -tulosraportti 12.2. | ||
2025 Q3 -tulosraportti 5.11.2025 | ||
2025 Q2 -tulosraportti 15.8.2025 | ||
2025 Q1 -tulosraportti 7.5.2025 |
Foorumi
Liity keskusteluun Nordnet Socialissa
Kirjaudu
- ·10.7.Another lovely summer day to be 55% down on :)
- ·3.7.Short-term, this is a gamble, with very great potential, one wonders what the market thinks, is one burned by previous setbacks or does one see an approval in the near future? Long-term, this will go well is my thought.Nilopki has received a rejection once (June 2026). Dasynoc has received a rejection once before (October 2025) and is now in its second review round with the FDA, with a PDUFA date in August. So, third time's the charm 😅
- ·26.6.Are the machines in order now so there won't be impurities and stains in the manufacturing process. Have they test-run them properly?
- ·26.6.I see this as good opportunities, wise to arrange a meeting so that one kind of collaborates with FDA in a constructive way, which should speed up the process. 👌👍Asked AI what it's worth now, (anyway, an approval will come sooner or later) We owners have been severely tested so far, but surely we see the goal now! Question: Given previous experience with the timeline, will FDA manage to conduct an inspection and document it before PDUFA August 25, 2026? Answer: Yes, time-wise it is entirely possible for FDA to manage both inspection and documentation before the PDUFA date of August 25, 2026, but the time margin is extremely tight. Based on experience and historically, there are three critical factors and precedents that determine if they succeed in hitting this window of approximately two months: 1. FDA's standardized lead times Inspection length: A foreign routine or Pre-Approval Inspection (PAI) on-site at a contract manufacturer like NerPharMa usually takes 5 to 10 business days. Documentation (Form 483): If inspectors find deficiencies, a so-called Form 483 protocol is issued directly on the last day of the inspection. The company then has 15 business days to respond. Final Report (EIR): If the inspection is completely clean (or "VAI" – Voluntary Action Indicated), FDA writes its internal final report (Establishment Inspection Report) within 30 to 45 days. 2. Mutual Recognition (MRA) accelerates the process The absolute biggest time-saving factor in this case is that NerPharMa is located in Italy. The USA and EU have a Mutual Recognition Agreement (MRA). Since the Italian Medicines Agency (AIFA) has just completed a successful inspection of the facility, FDA can theoretically choose to: Waive the manufacturing risk based on AIFA's documentation. Conduct a significantly shortened or entirely focused desk inspection (Remote Regulatory Assessment) instead of sending personnel physically from the USA, which saves weeks in logistics. 3. Risk of PDUFA extension (Major Amendment) If FDA chooses to conduct a physical on-site inspection in Italy during July/August, and requires Xspray or NerPharMa to submit significant amounts of new data in response to the inspection, this is often classified as a "Major Amendment". Given previous experience with FDA's regulations, the agency then automatically moves the PDUFA date forward by 3 months to give its reviewers time to go through the new data. Conclusion The review of Dasynoc is already in its final phase with ongoing labeling, which shows that FDA is actively working in the system to reach the goal in August. Thanks to the recent AIFA inspection, FDA has the necessary documentation to act quickly. However, if a physical inspection is required, it must be scheduled and carried out in the coming weeks of July for the timeline to hold without being postponed until late autumn 2026.
Yllä olevat kommentit ovat peräisin Nordnetin sosiaalisen verkoston Nordnet Socialin 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
Ei dataa
Viimeisimmät kaupat
| Aika | Hinta | Määrä | Ostaja | Myyjä |
|---|---|---|---|---|
| - | - | - | - |
Huomioi, että vaikka osakkeisiin säästäminen on pitkällä aikavälillä tuottanut hyvin, tulevasta tuotosta ei ole takeita. On olemassa riski, että et saa sijoittamiasi varoja takaisin.
Välittäjätilasto
Dataa ei löytynyt