It'll be nice to see if we file an AD NDA at this stage. The FDA meeting will have to be reasonably encouraging for us to take that step. The regulator will like our passing one co-primary and the key secondary results, the two positive biomarker results, and our oral delivery with positive safety and reasonable tolerability.
To accept an NDA at this stage, they'd have to get comfortable with primarily two things. Our phase 2/3 sample size is very small compared to other AD applications (500 vs 2,700 to 5,000). And of course the statistically failed co-primary.
In addition to the failed co-primary, the company has chosen not to fully disclose the dose and "precision medicine" wtS1 sub groups. Lack of public transparency hurts public credibility, but is a non-factor for drug regulators: barring a stupid mistake (resulting in the rare RTF Letter), the NDA will have to show all relevant data: beauty marks, warts, and tumors. The FDA concerns itself with complete NDAs, not poor TLRs and company spin.
So the absence of stat-sig dose response is a slight negative. Dose response has obvious clinical implications, so the lack of it will give the FDA pause when considering AA. If they decline AA, it would likely have been a factor in that decision along with small sample size and ADL for wanting to see a big full phase 3.
If (if) we end up filing an NDA soon, there's about a 90% chance we'll hear about it, and I believe about a 90% chance it will be accepted. As for that chance that we'll file, hard to say. The company clearly thinks they will, but you can't rely on that.
Watch for any word on FDA meeting and outcome.
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