you may be right about this. In reality, the hist
Post# of 139368
(Total Views: 408)
Posted On: 11/16/2023 9:08:07 PM
you may be right about this. In reality, the history of this stock price is written in violent moves up (and long drawn out declines). So if we do have a big positive catalyst, i agree there is the potential for a massive move in a short period of time.
so it really comes down to how quickly the hold is lifted. my biggest nagging concern on having the hold lifted is this:
The original hold inquiry was 5 tangible items i think. Cyrus laid them out, and actually kept us updated on the progress ("we've completed 3 of the 5", etc.). So we had a pretty black and white list of deliverables - which as far as i can understand, we delivered. The hold should then have been lifted - because the hold was based on 2 deaths and the concern they were tied our drug, and we proved they were not.
This second inquiry (i.e. wild goose chase) veered of the topic of safety - and to me seemed more amorphous - i'm not sure as an investor i ever saw the exact list of items? I know it included future plans for HIV, meetings with Key Opinion Leaders, etc. A lot of information was provided to the FDA - some seemingly subjective vs. objective (i.e. KOL feedback).
My point is - if the FDA didn't lift the safety-related hold when we clearly delivered 5 tangible items to show the drug's safety - what are the chances they simply lift the hold without further questions when the deliverables seemed so much more random, subjective and less concrete?
Hopefully - they look at the original submission (showing the drug is safe) and then say "ok, these guys did a lot of work - let's throw them a bone, because the hold should have been lifted already anyway". That would be the reasonable approach. But we're dealing with the FDA here - not the most reasonable group...
so it really comes down to how quickly the hold is lifted. my biggest nagging concern on having the hold lifted is this:
The original hold inquiry was 5 tangible items i think. Cyrus laid them out, and actually kept us updated on the progress ("we've completed 3 of the 5", etc.). So we had a pretty black and white list of deliverables - which as far as i can understand, we delivered. The hold should then have been lifted - because the hold was based on 2 deaths and the concern they were tied our drug, and we proved they were not.
This second inquiry (i.e. wild goose chase) veered of the topic of safety - and to me seemed more amorphous - i'm not sure as an investor i ever saw the exact list of items? I know it included future plans for HIV, meetings with Key Opinion Leaders, etc. A lot of information was provided to the FDA - some seemingly subjective vs. objective (i.e. KOL feedback).
My point is - if the FDA didn't lift the safety-related hold when we clearly delivered 5 tangible items to show the drug's safety - what are the chances they simply lift the hold without further questions when the deliverables seemed so much more random, subjective and less concrete?
Hopefully - they look at the original submission (showing the drug is safe) and then say "ok, these guys did a lot of work - let's throw them a bone, because the hold should have been lifted already anyway". That would be the reasonable approach. But we're dealing with the FDA here - not the most reasonable group...
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