- agreed that the data from the 30 pts with TNBC i
Post# of 148336
Quote:
- agreed that the data from the 30 pts with TNBC in the Ph1b/2 study is impressive
-concerned that Cytodyn has not yet moved into a Ph 2 or 3 study with the drug. Typically, a company would capitalize on this type of data release by swiftly moving into next stage of development
As you say it is a phase 1b/2 study. Phase 1b was safety and dosage escalation. That has been done and it has automatically gone into phase 2.
Quote:
it does not bode well that the company ignored the FDA’s comments about appropriate design of the COVID study
The company did listen to the FDA (not a choice really) and that's why we got 2 doses instead of four. Your BIL seems to have a misunderstanding.
Quote:
Unsure what this means, but a displeased and vocal investor group is typically associated with management mistakes and/or wrongdoing.
Yes Cytodyn management has made mistakes. But the majority of activist investors that push a 13d proxy do so to enrich themselves at the expense of everyone else.
Quote:
it’s not clear, based on publicity available info, what the patent situation is with the drug. As the drug has been in development for many years, there may be minimal residual patent life, if the drug is ever approved for use.
Tell your BIL about FDA 12 year exclusivity.