RE:AA requires proof of enrollment I don't see any problems here. Clearly laid out in FDA trial guidelines for NMIBC is the fact that if AA is granted, then completion of the same trial could be used as a confirmatory trial. They already treated 50% of patients, so another 50-60 patients from here, and if they get AA, then by that time they may have already enrolled 70-80 patients IMHO Enrolling after AA is not hard, as this is a single arm ( no placebo group) so everyone enrolled gets treated for free when others need to pay or insurance IMHO
N0taP00p wrote: From what I've read, the FDA will require that the company being granted the AA satisfy the FDA wrt enrollment numbers for the confirmatory study to be executed in support of the early approval. It's a tough spot to be in for a small company. I couldn't tell if there was any leeway or what the numbers should be. But apparently, the FDA is being careful because many companies did not follow through after AA. Our best bet might still be an offer for a JV with a big pharma for a two-drug combo. I suspect that will have to wait till Theralase actually submits their application with 450 day data to back it up.