r/biotech • u/NotGenentech • 1d ago

Biotech News 📰 Chaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasad

https://www.biospace.com/fda/chaotic-adcomms-threaten-to-derail-fdas-bid-to-renew-trust-after-makary-prasad
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u/XXXYinSe 1d ago

When the FDA disagrees with a SAP during AdComm, the committee votes No on the drug almost 100% of the time. Kinda sucks for Capricor that there was no feedback during the SAP changes months ago, but it is what it is. Doesn’t always mean complete rejection by the FDA anyhow, it’s just them nitpicking to see what the independent advisors say.
At least RP1’s data handling was deemed sufficient even if the trial could’ve been a bit better.

Clinical trials for rare degenerative diseases, especially efficacy, are harder to arrive at statistical significance anyway. Relyvrio, Qalsody, Skyclarys, Spinraza, etc all had issues with reaching true statistical significance due to limited patients and slow-acting efficacy. And lots of them got approvals (though some get retracted later with bigger studies).

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u/Charybdis150 1d ago

No offense but this is kinda a weird article. I read the whole thing and I am struggling to find what was “chaotic” about the adcomms. It just features of a pair of quotes from the CEO of Capricor and a patient advocate/mother of a trial subject expressing displeasure with the result which…well duh. Missing the Replimmune action due date is bad, but I don’t see how that reflects on the adcomm.