2026 Q1 -tulosraportti
94 päivää sitten
‧22 min
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: Quartr| Seuraava tapahtuma | |
|---|---|
2026 Q2 -tulosraportti 20.8. | 6 päivää |
| Menneet tapahtumat | ||
|---|---|---|
2026 Q1 -tulosraportti 12.5. | ||
2025 Q4 -tulosraportti 5.2. | ||
2025 Q3 -tulosraportti 5.11.2025 | ||
2025 Q2 -tulosraportti 21.8.2025 | ||
2025 Q1 -tulosraportti 16.5.2025 |
Asiakkaat katsoivat myös
Foorumi
Liity keskusteluun Nordnet Socialissa
Kirjaudu
·4.8.Anyone who knows anything??I have sold a good portion at the bottom, because the risk after all is greater than before, no one knows anything about whether they can move on from here. It is very uncertain. Have bought another high-risk stock for the money 😀 But always a possibility that some know something we haven't been told yet. Maybe it has dawned on people that it fell too much?
·3.8.Haven't we received any updates regarding the meeting with FDA?
·21.7.It is not enough to merely reproduce FDA's CRL and then assume that every formulation must be the only correct description of what has actually happened. FDA is naturally the deciding authority, but that does not mean that their reasoning cannot contain misunderstandings, incomplete or incorrect assumptions, or questions that need to be addressed. When it comes to Ascelia, there are clear contradictions and question marks. Further down, I have linked to a well-known American legal blog, run by the law firm Hyman, Phelps & McNamara, P.C. They specialize in FDA and life science law. And they help companies, among other things, with appeals against FDA’s CRL. They clearly explain in the article I link to, how “denied”/rejection in their appeal cases concerning CRL is often a win, even though FDA’s statistics say it’s a loss. 7 out of 9 products received an alternative and more favorable path to approval, which we consider wins, they write on their blog. And as I described in an earlier post, it has been chaotic at the FDA, to say the least, with thousands of layoffs - only to now rehire almost the same number that were previously dismissed. There are several articles where, among others, current or former FDA employees testify that it is difficult to keep up with reviews of drug applications. But that they have not yet fallen behind on the important PDUFA date. Instead, the CRLs have increased - because that also counts as a decision and thus they meet the PDUFA date. “They are buying themselves time,” several articles state. “Irrelevant” questions can be raised in a CRL - to buy time. Which a law firm has described and which I previously linked to. That was from 2015, but it feels more relevant now - than then. That there is no discussion about FDA’s CRL decision, based on the fact that their operations have undergone major changes that have obviously affected employees and applicant companies, feels strange. The contradictions in Ascelia’s CRL, the majority of those writing on the Avanza forum seem determined that it is solely due to incorrect implementations by Ascelia. The reasoning automatically becomes negatively biased against Ascelia - because FDA is a sacred institution that makes no mistakes. And anyone who tries to reason about it is trying to pump the stock… CONTRADICTORY POINTS IN ASCELIA’S CRL FDA Treats 1st Reading as a Failed Study Result FDA writes that SPARKLE did not meet its predefined success criteria because only one of the three original radiologists showed statistical superiority for both primary endpoints. But this describes the first reading as if it had generated a valid negative efficacy result. This is not how Ascelia previously described the situation. Already in August 2023, the company announced that two out of three readers had unacceptably high intra-reader variability. This means that the same radiologist gave highly varying assessments when the same images were shown at different times. The problem also existed in all image series, even in the unenhanced images. The company’s conclusion was therefore not that SPARKLE had shown a negative result. The conclusion was that the readers’ scoring was so inconsistent that no reliable conclusion about the effect could be drawn. Ascelia has also stated that the company subsequently had a regulatory dialogue with the FDA on how the situation should be handled. According to the company, the continued strategy was discussed with the authority, and FDA’s feedback was later incorporated into the NDA application. If this is true, it becomes difficult to understand FDA’s reasoning. If the authority already previously considered the first image review to be so deficient that a new independent review needed to be carried out, why is the first review then used as the main argument for the study not meeting the requirements? The Rereading Was Not a Post-Hoc Construction by Ascelia FDA calls the rereading “post hoc” and writes that it “was not adequately justified.” But Ascelia states that the problems with the first reading, as well as the subsequent method for evaluating the images, were discussed with the FDA and that the authority’s feedback was incorporated into the NDA application. It seems unlikely that a small company would risk its entire sole registration-enabling study by independently constructing a new reading process without regulatory dialogue. The company had everything to lose by deviating from what the FDA could accept.
- ·16.7.There has been a discussion on Avanza, or rather, a lot of incorrect information has been circulating. Which is clearly put out for a single purpose. Among other things, the question has been whether the radiologists had access to all sequence images or only T1. Ascelia has been clear that SPARKLE encompassed a complete MR examination with T1-, T2- and DWI-sequences. This is also evident from the study protocol, where all image material was collected and evaluated. Furthermore, Ascelia describes after the successful re-read, in the 2024 annual report, the primary endpoint as: "Non-enhanced MR + Orviglance MR vs. Non-enhanced MR." And not: "T1 vs T1". There is an image in the annual report that relates to this text. But I don't see that I can attach images on Nordnet. The readers/radiologists had access to the entire MR examination, which also aligns with the company's PM after the CRL. The FDA, however, states in the CRL that the re-read "restricted lesion scoring to T1-weighted images". It is an important difference. That lesion scoring was restricted to T1 is not the same as radiologists only being shown T1 images. What is being compared is the same non-enhanced MR examination in both groups. One group then also has Orviglance-enhanced T1 images. Radiologists compare two identical MR examinations where the only variable added is Orviglance. The T2- and DWI-images are the same non-enhanced images in both groups. Of course, they are important. They help the radiologist find and assess the lesions and provide a better basis for decision-making. But they are not what differentiates the groups. What actually differentiates the groups is Orviglance, and Orviglance affects the T1 images, not T2 or DWI. Therefore, it is not strange that the actual lesion scoring was done on T1, while the radiologists had access to the entire MR examination with T1, T2 and DWI.Below is text that was included in the attached image from the 2024 annual report. "The results from the secondary endpoints generally support Orviglance's superiority compared to MR without contrast agent (unenhanced MR), e.g., with at least one additional detected lesion in 40-52 percent of patients with Orviglance between readers. No analysis favors MR without contrast agent. This includes, for example, lesion detection and subgroup analysis of patients. Orviglance's superiority compared to unenhanced MR was demonstrated regardless of whether unenhanced images were compared with images with Orviglance combined with unenhanced images or images with Orviglance alone." "The evaluation of the primary endpoint was performed independently by three blinded radiologists (readers) according to regulatory guidelines. The readers assessed both changes in the visualization of liver lesions with and without Orviglance (the primary endpoint), as well as other secondary endpoints." "The Phase 3 study was designed in accordance with industry standards, regulatory guidance for the development of imaging examinations, and based on discussions with regulatory authorities. The study aims to support a regulatory application and approval for the use of Orviglance for liver imaging in patients where the use of gadolinium may be medically inadvisable."
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.
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
94 päivää sitten
‧22 min
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
- ·4.8.Anyone who knows anything??I have sold a good portion at the bottom, because the risk after all is greater than before, no one knows anything about whether they can move on from here. It is very uncertain. Have bought another high-risk stock for the money 😀 But always a possibility that some know something we haven't been told yet. Maybe it has dawned on people that it fell too much?
- ·3.8.Haven't we received any updates regarding the meeting with FDA?
- ·21.7.It is not enough to merely reproduce FDA's CRL and then assume that every formulation must be the only correct description of what has actually happened. FDA is naturally the deciding authority, but that does not mean that their reasoning cannot contain misunderstandings, incomplete or incorrect assumptions, or questions that need to be addressed. When it comes to Ascelia, there are clear contradictions and question marks. Further down, I have linked to a well-known American legal blog, run by the law firm Hyman, Phelps & McNamara, P.C. They specialize in FDA and life science law. And they help companies, among other things, with appeals against FDA’s CRL. They clearly explain in the article I link to, how “denied”/rejection in their appeal cases concerning CRL is often a win, even though FDA’s statistics say it’s a loss. 7 out of 9 products received an alternative and more favorable path to approval, which we consider wins, they write on their blog. And as I described in an earlier post, it has been chaotic at the FDA, to say the least, with thousands of layoffs - only to now rehire almost the same number that were previously dismissed. There are several articles where, among others, current or former FDA employees testify that it is difficult to keep up with reviews of drug applications. But that they have not yet fallen behind on the important PDUFA date. Instead, the CRLs have increased - because that also counts as a decision and thus they meet the PDUFA date. “They are buying themselves time,” several articles state. “Irrelevant” questions can be raised in a CRL - to buy time. Which a law firm has described and which I previously linked to. That was from 2015, but it feels more relevant now - than then. That there is no discussion about FDA’s CRL decision, based on the fact that their operations have undergone major changes that have obviously affected employees and applicant companies, feels strange. The contradictions in Ascelia’s CRL, the majority of those writing on the Avanza forum seem determined that it is solely due to incorrect implementations by Ascelia. The reasoning automatically becomes negatively biased against Ascelia - because FDA is a sacred institution that makes no mistakes. And anyone who tries to reason about it is trying to pump the stock… CONTRADICTORY POINTS IN ASCELIA’S CRL FDA Treats 1st Reading as a Failed Study Result FDA writes that SPARKLE did not meet its predefined success criteria because only one of the three original radiologists showed statistical superiority for both primary endpoints. But this describes the first reading as if it had generated a valid negative efficacy result. This is not how Ascelia previously described the situation. Already in August 2023, the company announced that two out of three readers had unacceptably high intra-reader variability. This means that the same radiologist gave highly varying assessments when the same images were shown at different times. The problem also existed in all image series, even in the unenhanced images. The company’s conclusion was therefore not that SPARKLE had shown a negative result. The conclusion was that the readers’ scoring was so inconsistent that no reliable conclusion about the effect could be drawn. Ascelia has also stated that the company subsequently had a regulatory dialogue with the FDA on how the situation should be handled. According to the company, the continued strategy was discussed with the authority, and FDA’s feedback was later incorporated into the NDA application. If this is true, it becomes difficult to understand FDA’s reasoning. If the authority already previously considered the first image review to be so deficient that a new independent review needed to be carried out, why is the first review then used as the main argument for the study not meeting the requirements? The Rereading Was Not a Post-Hoc Construction by Ascelia FDA calls the rereading “post hoc” and writes that it “was not adequately justified.” But Ascelia states that the problems with the first reading, as well as the subsequent method for evaluating the images, were discussed with the FDA and that the authority’s feedback was incorporated into the NDA application. It seems unlikely that a small company would risk its entire sole registration-enabling study by independently constructing a new reading process without regulatory dialogue. The company had everything to lose by deviating from what the FDA could accept.
- ·16.7.There has been a discussion on Avanza, or rather, a lot of incorrect information has been circulating. Which is clearly put out for a single purpose. Among other things, the question has been whether the radiologists had access to all sequence images or only T1. Ascelia has been clear that SPARKLE encompassed a complete MR examination with T1-, T2- and DWI-sequences. This is also evident from the study protocol, where all image material was collected and evaluated. Furthermore, Ascelia describes after the successful re-read, in the 2024 annual report, the primary endpoint as: "Non-enhanced MR + Orviglance MR vs. Non-enhanced MR." And not: "T1 vs T1". There is an image in the annual report that relates to this text. But I don't see that I can attach images on Nordnet. The readers/radiologists had access to the entire MR examination, which also aligns with the company's PM after the CRL. The FDA, however, states in the CRL that the re-read "restricted lesion scoring to T1-weighted images". It is an important difference. That lesion scoring was restricted to T1 is not the same as radiologists only being shown T1 images. What is being compared is the same non-enhanced MR examination in both groups. One group then also has Orviglance-enhanced T1 images. Radiologists compare two identical MR examinations where the only variable added is Orviglance. The T2- and DWI-images are the same non-enhanced images in both groups. Of course, they are important. They help the radiologist find and assess the lesions and provide a better basis for decision-making. But they are not what differentiates the groups. What actually differentiates the groups is Orviglance, and Orviglance affects the T1 images, not T2 or DWI. Therefore, it is not strange that the actual lesion scoring was done on T1, while the radiologists had access to the entire MR examination with T1, T2 and DWI.Below is text that was included in the attached image from the 2024 annual report. "The results from the secondary endpoints generally support Orviglance's superiority compared to MR without contrast agent (unenhanced MR), e.g., with at least one additional detected lesion in 40-52 percent of patients with Orviglance between readers. No analysis favors MR without contrast agent. This includes, for example, lesion detection and subgroup analysis of patients. Orviglance's superiority compared to unenhanced MR was demonstrated regardless of whether unenhanced images were compared with images with Orviglance combined with unenhanced images or images with Orviglance alone." "The evaluation of the primary endpoint was performed independently by three blinded radiologists (readers) according to regulatory guidelines. The readers assessed both changes in the visualization of liver lesions with and without Orviglance (the primary endpoint), as well as other secondary endpoints." "The Phase 3 study was designed in accordance with industry standards, regulatory guidance for the development of imaging examinations, and based on discussions with regulatory authorities. The study aims to support a regulatory application and approval for the use of Orviglance for liver imaging in patients where the use of gadolinium may be medically inadvisable."
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: Quartr| Seuraava tapahtuma | |
|---|---|
2026 Q2 -tulosraportti 20.8. | 6 päivää |
| Menneet tapahtumat | ||
|---|---|---|
2026 Q1 -tulosraportti 12.5. | ||
2025 Q4 -tulosraportti 5.2. | ||
2025 Q3 -tulosraportti 5.11.2025 | ||
2025 Q2 -tulosraportti 21.8.2025 | ||
2025 Q1 -tulosraportti 16.5.2025 |
2026 Q1 -tulosraportti
94 päivää sitten
‧22 min
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: Quartr| Seuraava tapahtuma | |
|---|---|
2026 Q2 -tulosraportti 20.8. | 6 päivää |
| Menneet tapahtumat | ||
|---|---|---|
2026 Q1 -tulosraportti 12.5. | ||
2025 Q4 -tulosraportti 5.2. | ||
2025 Q3 -tulosraportti 5.11.2025 | ||
2025 Q2 -tulosraportti 21.8.2025 | ||
2025 Q1 -tulosraportti 16.5.2025 |
Foorumi
Liity keskusteluun Nordnet Socialissa
Kirjaudu
- ·4.8.Anyone who knows anything??I have sold a good portion at the bottom, because the risk after all is greater than before, no one knows anything about whether they can move on from here. It is very uncertain. Have bought another high-risk stock for the money 😀 But always a possibility that some know something we haven't been told yet. Maybe it has dawned on people that it fell too much?
- ·3.8.Haven't we received any updates regarding the meeting with FDA?
- ·21.7.It is not enough to merely reproduce FDA's CRL and then assume that every formulation must be the only correct description of what has actually happened. FDA is naturally the deciding authority, but that does not mean that their reasoning cannot contain misunderstandings, incomplete or incorrect assumptions, or questions that need to be addressed. When it comes to Ascelia, there are clear contradictions and question marks. Further down, I have linked to a well-known American legal blog, run by the law firm Hyman, Phelps & McNamara, P.C. They specialize in FDA and life science law. And they help companies, among other things, with appeals against FDA’s CRL. They clearly explain in the article I link to, how “denied”/rejection in their appeal cases concerning CRL is often a win, even though FDA’s statistics say it’s a loss. 7 out of 9 products received an alternative and more favorable path to approval, which we consider wins, they write on their blog. And as I described in an earlier post, it has been chaotic at the FDA, to say the least, with thousands of layoffs - only to now rehire almost the same number that were previously dismissed. There are several articles where, among others, current or former FDA employees testify that it is difficult to keep up with reviews of drug applications. But that they have not yet fallen behind on the important PDUFA date. Instead, the CRLs have increased - because that also counts as a decision and thus they meet the PDUFA date. “They are buying themselves time,” several articles state. “Irrelevant” questions can be raised in a CRL - to buy time. Which a law firm has described and which I previously linked to. That was from 2015, but it feels more relevant now - than then. That there is no discussion about FDA’s CRL decision, based on the fact that their operations have undergone major changes that have obviously affected employees and applicant companies, feels strange. The contradictions in Ascelia’s CRL, the majority of those writing on the Avanza forum seem determined that it is solely due to incorrect implementations by Ascelia. The reasoning automatically becomes negatively biased against Ascelia - because FDA is a sacred institution that makes no mistakes. And anyone who tries to reason about it is trying to pump the stock… CONTRADICTORY POINTS IN ASCELIA’S CRL FDA Treats 1st Reading as a Failed Study Result FDA writes that SPARKLE did not meet its predefined success criteria because only one of the three original radiologists showed statistical superiority for both primary endpoints. But this describes the first reading as if it had generated a valid negative efficacy result. This is not how Ascelia previously described the situation. Already in August 2023, the company announced that two out of three readers had unacceptably high intra-reader variability. This means that the same radiologist gave highly varying assessments when the same images were shown at different times. The problem also existed in all image series, even in the unenhanced images. The company’s conclusion was therefore not that SPARKLE had shown a negative result. The conclusion was that the readers’ scoring was so inconsistent that no reliable conclusion about the effect could be drawn. Ascelia has also stated that the company subsequently had a regulatory dialogue with the FDA on how the situation should be handled. According to the company, the continued strategy was discussed with the authority, and FDA’s feedback was later incorporated into the NDA application. If this is true, it becomes difficult to understand FDA’s reasoning. If the authority already previously considered the first image review to be so deficient that a new independent review needed to be carried out, why is the first review then used as the main argument for the study not meeting the requirements? The Rereading Was Not a Post-Hoc Construction by Ascelia FDA calls the rereading “post hoc” and writes that it “was not adequately justified.” But Ascelia states that the problems with the first reading, as well as the subsequent method for evaluating the images, were discussed with the FDA and that the authority’s feedback was incorporated into the NDA application. It seems unlikely that a small company would risk its entire sole registration-enabling study by independently constructing a new reading process without regulatory dialogue. The company had everything to lose by deviating from what the FDA could accept.
- ·16.7.There has been a discussion on Avanza, or rather, a lot of incorrect information has been circulating. Which is clearly put out for a single purpose. Among other things, the question has been whether the radiologists had access to all sequence images or only T1. Ascelia has been clear that SPARKLE encompassed a complete MR examination with T1-, T2- and DWI-sequences. This is also evident from the study protocol, where all image material was collected and evaluated. Furthermore, Ascelia describes after the successful re-read, in the 2024 annual report, the primary endpoint as: "Non-enhanced MR + Orviglance MR vs. Non-enhanced MR." And not: "T1 vs T1". There is an image in the annual report that relates to this text. But I don't see that I can attach images on Nordnet. The readers/radiologists had access to the entire MR examination, which also aligns with the company's PM after the CRL. The FDA, however, states in the CRL that the re-read "restricted lesion scoring to T1-weighted images". It is an important difference. That lesion scoring was restricted to T1 is not the same as radiologists only being shown T1 images. What is being compared is the same non-enhanced MR examination in both groups. One group then also has Orviglance-enhanced T1 images. Radiologists compare two identical MR examinations where the only variable added is Orviglance. The T2- and DWI-images are the same non-enhanced images in both groups. Of course, they are important. They help the radiologist find and assess the lesions and provide a better basis for decision-making. But they are not what differentiates the groups. What actually differentiates the groups is Orviglance, and Orviglance affects the T1 images, not T2 or DWI. Therefore, it is not strange that the actual lesion scoring was done on T1, while the radiologists had access to the entire MR examination with T1, T2 and DWI.Below is text that was included in the attached image from the 2024 annual report. "The results from the secondary endpoints generally support Orviglance's superiority compared to MR without contrast agent (unenhanced MR), e.g., with at least one additional detected lesion in 40-52 percent of patients with Orviglance between readers. No analysis favors MR without contrast agent. This includes, for example, lesion detection and subgroup analysis of patients. Orviglance's superiority compared to unenhanced MR was demonstrated regardless of whether unenhanced images were compared with images with Orviglance combined with unenhanced images or images with Orviglance alone." "The evaluation of the primary endpoint was performed independently by three blinded radiologists (readers) according to regulatory guidelines. The readers assessed both changes in the visualization of liver lesions with and without Orviglance (the primary endpoint), as well as other secondary endpoints." "The Phase 3 study was designed in accordance with industry standards, regulatory guidance for the development of imaging examinations, and based on discussions with regulatory authorities. The study aims to support a regulatory application and approval for the use of Orviglance for liver imaging in patients where the use of gadolinium may be medically inadvisable."
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