Ascelia Pharma är ett läkemedelsbolag. Bolaget är specialiserat inom utveckling av särläkemedel inom onkologi (cancer). Bolaget utvecklar diverse läkemedelskandidater, där störst användning återfinns inom behandling av cancer som drabbat lever och magsäck. Bolaget grundades år 2000 och har huvudkontor i Malmö, Sverige, men är verksamt på en global marknad.
Following the FDA's Complete Response Letter for Orviglance and the subsequent publication of the redacted letter, we set out what the current share price implies, the scenarios we see into the Type A meeting, and our reading of the clinical issue at the centre of the case.
The FDA's Complete Response Letter (CRL) for Orviglance (NDA 220544) is now publicly accessible in redacted form through the FDA's openFDA transparency database. The letter's specifics raise the odds of a more demanding path to approval than previously indicated.
* CRL questions SPARKLE endpoint analysis; re-read rejected *Ascelia disputes both points; expresses confidence * Type A meeting next; outcomes range widely The CRL's stated grounds In the CRL (Complete Response Letter), the FDA states that SPARKLE failed...
Ascelia Pharma provided a follow-up update yesterday, July 12, on the Complete Response Letter received on July 3. This is the first substantive detail the company has disclosed on the nature of the FDA's clinical concerns since the CRL, and it meaningfully narrows, though does not close, the range of scenarios we flagged in our July 3 note.
* Additional clinical data and product documentation requested * Urgent FDA meeting to discuss next steps * Very low visibility: Valuation suspended until more clarity Additional clinical data and product documentation requested Ascelia Pharma announced...
Ascelia Pharma today received a Complete Response Letter (CRL) from the FDA. The FDA stated it cannot approve the application for Orviglance in its present form and has requested additional clinical data and product documentation. This alters the investment case materially, and feedback from the Type A meeting with the FDA is the main short-term catalyst
