InvestorsHub Logo
Followers 89
Posts 17450
Boards Moderated 0
Alias Born 09/06/2006

Re: HyGro post# 544606

Tuesday, 12/06/2022 12:11:30 PM

Tuesday, December 06, 2022 12:11:30 PM

Post# of 703926
The FDA does vet that any change will not harm patients.

Kind of a low bar here as all it means is that an analysis change made years after the last patient was treated could not harm them.

No RA has said that the changed trial protocol is valid for the purpose of approval.

There are many trials, even P3s, where the protocol is not even intended by the sponsor to support approval. It is not up to the RAs to say a sponsor cannot run a trial just because it will not yield approvable data.
Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent NWBO News