It is clear to all of us that Acadia / Neuren's initiative to suspend Trofinetide due to Covid19 is part of a small percentage compared to all the other trials of all kinds that have not been suspended, including those that most resemble us.in recent years, I have witnessed some cases in which FDA has approved drugs for unsatisfied therapies even in phase 2, in the context in which they already showed absence of toxicity accompanied by a fair efficacy, essentially what Neuren has already shown in its phase 2.what I suspect and which in the light of the facts now I argue is that the suspension of Trofinetide for Covid 19 is a strategy to arrive at an early approval by the FDA. there is no doubt that we already have all the requirements to obtain it and I am referring to the granting of Priority Review, Orphan Drug and Rare Pediatric Disease.this is the last case of mid-April last to make a serious reflection. Phase 2 trial, suspended for Covid 19 and approved by the FDA for the requirements of which Trofinetide is in full compliance. following the links on which to consult.
https://www.prnewswire.com/news-releases/fda-approves-first-therapy-for-children-with-debilitating-and-disfiguring-rare-disease-301038879.html
https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-children-debilitating-and-disfiguring-rare-disease
https://finance.yahoo.com/news/astrazenecas-koselugo-gets-fda-nod-161704243.html
https://clinicaltrials.gov/ct2/show/NCT03213691?term=Koselugo&draw=2&rank=1
lastly, I would like to point out that the positive rebound from the 1 dollar fund matured in the days of April of the news that I posted.
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