InvestorsHub Logo

Steady_T

01/14/23 3:48 PM

#398262 RE: sab63090 #398242

I would not be surprised if the company is focused on preparing a clinical trial report for the agencies. Missling has said that he wants to have meetings with the agencies on the path forward.

Getting a determination on whether or not this trial will be considered pivotal or require an additional P3 is a crucial piece of information. Missling has always been very quiet on the company's meetings and relationship with the FDA. He may think that putting out the TLD prior to having the meeting with the FDA and getting that important decision may be considered "pushing" the FDA and that is something to be avoided. Just considering possibilities.

If that is the case, Anavex gets an approval on the trial as pivotal and Missling publishes the data to support that decision. At that point the market and experienced biotech investors will take the data much more seriously with the resulting positive impact on the SP.

I'd call this a rosy scenario.