A really good observation by "stockorus" on Ihub.
Post# of 154851
(Total Views: 549)
Posted On: 02/26/2021 11:33:01 AM
A really good observation by "stockorus" on Ihub.
I am far too literal, and usually miss these types of observations.
He wrote:
I am far too literal, and usually miss these types of observations.
He wrote:
Quote:
Cytodyn has sent the data to FDA, MHRA and Health Canada to discuss "path going forward". I can understand that with the FDA, this might mean 1. approval or EUA 2. expand trial size 3. do another trial with different indication, etc.
But what exactly would Cytodyn want to discuss with Health Canada and MHRA? It seems the only path-going-forward that these agencies can meaningfully suggest or Cytodyn would be interested in discussing with them would be about some kind of approval. If Cytodyn knows such outcome is unlikely, they would just want FDA's input instead of discussing alternate future routes with MHRA and HC.
So the fact that we are discussing simultaneously with Canada and UK on the data is highly suggesting there is a compelling case to make for approval. Data may or may not be ideal; but I think it must be good enough to warrant discussion with other agencies *for approval*.
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