(Total Views: 767)
Posted On: 03/30/2022 7:59:20 PM
Post# of 148899
People have got to calm down, news wasn't all that catastrophic, in fact I'm encouraged by hiring of Dr. Brunke. Another experienced polished professional on board.
As for the HIV announcement, I thought the PR was a bit incomplete or misleading. One sentence says the FDA "placed a partial clinical hold on it's HIV program" - however in second paragraph it says " the company was not enrolling any new patients in the trials placed on hold AND partial clinical hold on the HIV program impacts patients currently enrolled in extension trials". Clarity, at least for me is needed and expected tomorrow.
The CMC section was submitted on Dec. 1st and the PR stated " CYDY completed submission of all the major sections of CMC module, SOME remaining supporting documentation will be submitted under Regional Information by end of the week". On the shareholders conference call Dr. Ray sounded reassured everything was fine as he knew at the time.
As for Brazil CV-19 trial, they PR'd on 12/8 that the Brazilian "CRO (AEIH) met with ANVISA and received it's AGREEMENT to modify the CD16 trial", thus reducing the patient enrollment from 330 to 126 with interim efficacy analysis by DSMB after 51 patients are enrolled and have completed follow-up to day 28". That was 80 days ago- so maybe results are in fact right around the corner- who knows?
The sky is not falling, lights not being turned out. Management is doing what it should be doing ", evaluating the most OPTIMAL programs on which to focus it's resources & attention". I find Dr. Ray, Dr. Kelly, Dr. Recknor & Antonio Migliarese to be men of integrity and anxious to hear from them tomorrow-
As for the HIV announcement, I thought the PR was a bit incomplete or misleading. One sentence says the FDA "placed a partial clinical hold on it's HIV program" - however in second paragraph it says " the company was not enrolling any new patients in the trials placed on hold AND partial clinical hold on the HIV program impacts patients currently enrolled in extension trials". Clarity, at least for me is needed and expected tomorrow.
The CMC section was submitted on Dec. 1st and the PR stated " CYDY completed submission of all the major sections of CMC module, SOME remaining supporting documentation will be submitted under Regional Information by end of the week". On the shareholders conference call Dr. Ray sounded reassured everything was fine as he knew at the time.
As for Brazil CV-19 trial, they PR'd on 12/8 that the Brazilian "CRO (AEIH) met with ANVISA and received it's AGREEMENT to modify the CD16 trial", thus reducing the patient enrollment from 330 to 126 with interim efficacy analysis by DSMB after 51 patients are enrolled and have completed follow-up to day 28". That was 80 days ago- so maybe results are in fact right around the corner- who knows?
The sky is not falling, lights not being turned out. Management is doing what it should be doing ", evaluating the most OPTIMAL programs on which to focus it's resources & attention". I find Dr. Ray, Dr. Kelly, Dr. Recknor & Antonio Migliarese to be men of integrity and anxious to hear from them tomorrow-
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