IND Re-submit RNS - Yes/No ?19 Aug 2023 16:16
HH,
As previous, In my opinion the next RNS will not be regarding Hemo' Car-T .
However on the H Car-T subject I think it's important to dispel the too convenient argument that the fix could have been made and re-submission already with the FDA.
...It's not and it's not !
With reference to your post.
1.It is not subjective ! They're literally the rules and should Hemo' apply their core value of "Integrity" to market comms, then they should and will RNS the re-submission. I think all would agree, if and when Hemo' are confident with their fix to the FDA highlighted deficiency and happy to present to the FDA, at THAT point, the SP would substantially move if same communicated to the market.
2.Hemo' have NOT told us they have solved the issue!
They have told us they have a method to solve the issue. It may appear like nit picking semantics, it's not, they are very, very different. Your assertion is incorrect.
I do agree with you that in general terms the most important factor is the FDA acceptance of a fix, if and when it's proposed.
However, strictly regarding the rules on RNS comms, the rules would dictate the need to RNS when Hemo' have determined they themselves have fixed the issue and re-submitted. It is not a subjective matter and as such it's not already done.
AIMO
Ps Genuinely glad you're back making lucid argument, even where we disagree. Before you say it, I know it's not mutual.
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"This is subjective
“In summary, issuers must notify without delay major new developments that may affect their business if the development may lead to a substantial share price movement.”
Hemo have already told us they have solved the single issue.
So whether you like it or not, I don't think submitting the paperwork is any more important that any other step required to address the 1 issue.
The significant thing is the FDA agreeing with Hemo that they have addressed the issue and lift the clinical hold
I have already "Priced In" the fact that Hemo will respond to FDA. So what matters to be is the response of the FDA"