Stock price - ATH/ATHE, page-1177

Hi itsa,

You say ...
“If we get clear biomarker efficacy and any [clinical] benefit, we will have a very active discussion with the FDA to accelerate approval and skip the next stage [a phase III trial],” Stamler says.“It depends on the strength of the data. With an untreated disease, if you show robust efficacy the FDA will take it seriously”.
IMO: says we might not have to do a Phase 3..

You've almost have it right ...

Note: from the FDA ...

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical ... Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

Simply, this means we may receive AA after the Phase 2, and thus be able to sell our drug ... once labeling etc is sorted ... and then we do the Phase 3 while we are already selling our product. The FDA likes to 'confirm' with a larger trial, even though we are already making money. All this with a partner I hope.

So, AA at Phase 2 is a 'jackpot', but then we will be asked to show how we will structure our Phase 3 trial, before we 'roll'. We don't have to have actually made a start on the Ph3. Anyway, that's how I understand it. Happy to see counter evidence.

As always, opinion only.