FBCoach, I stole this post from Whosonfirst on

FBCoach,

I stole this post from Whosonfirst on Ihub.

A reasonable assessment that I found calming and reasonable. We will know the reality Tuesday. He wrote:


Keep in mind normal process is DSMB makes a recommendation, lets sponsor (cytodyn) and FDA know that recommendation.

Webcast “will discuss the recommendations of the Data Safety Monitoring Committee (DSMC) following their review of the interim analysis of the first 195 patients enrolled in the Company’s Phase 2b/3 clinical trial for patients with severe-to-critical COVID-19 indications, including a potential regulatory path forward“

We already all know that the planned regulatory path forward would be to fill trial to 390. This Tuesday webcast must be to discuss another way toward regulatory approval. Most likely one much quicker than filling the trial.

We’re in a pandemic covid 2nd wave is already starting to show worse statistics than first wave. If we are told continue to fill trial which is how most all drugs get approved by continuing and hitting Pvalue we may hear that the it's in the FDA’s hands to decide on EUA or Approval without finishing trial.

If it was just continue trial and that’s it, I think there would be a Friday after hours PR stating we were recommended to finish phase 3 severe/critical trial.

So there def more than meets the eye here. Also if the regular process would be DSMC make a recommendation to the FDA we could very well get the FDA decision over the weekend or as soon as tomorrow. The Tuesday webcast could be to discuss want hasn’t yet been announced.