RE: RNS out2 Jun 2023 12:23
Agreed but the stock market and people who were looking at this stock now will be put off ... at least for some time and that is a real shame. None of us could believe days before the 30 days they would get this note but I wouldnt be surprised that vlad got this info some time back and didnt say. I really dont trust him and there have been so many instances where its been hyped up and then he suddenly does a placing or gives bad news.
This is from the FDA :-
A. What happens when the Agency imposes a clinical hold?
The Agency communicates the clinical hold to the sponsor, usually in a teleconference. After an
IND has been placed on clinical hold, the study may not be initiated until the applicant has
received a communication (via phone, fax, letter, or e-mail) from the Agency allowing the study
to proceed (21 CFR 312.42(e)).
Within 30 days from the date of the teleconference placing an IND on clinical hold, the Agency
must send the sponsor a clinical hold letter, signed by the Division Director or Acting Division
Director, that describes in detail the reasons for the clinical hold (21 CFR 312.42(d)). The
name of the responsible FDA contact will be included in the clinical hold lette