Will the FDA clinical hold be lifted quickly and is it even the main concern for Hemogenyx Car-T advancement?5 Jun 2023 08:08
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Q, Will the FDA clinical hold be lifted quickly and is it even the main concern for Hemogenyx Car-T advancement?
A, My opinion. No and no.
I’ll explain why with reference to independent and relevant scientific reports.
During the FDA IND review process, Hemogenyx should have been given the opportunity to address the FDA’s concerns.
This opportunity being the FDA’s standard procedure.
The fact that the FDA’s concerns were not addressed and they subsequently placed a clinical hold, confirms the issue(s) are not easily and quickly addressable.
So what are the issues, what’s the time line to resolve and are there other more serious issues for the advancement of Hemo’ Car-T?
Factually, I don’t know!
The company decided not to enlighten shareholders in advising what the FDA concerns are within the RNS announcement.
In the absence of Hemogenyx clarification on the issue(s), we can only turn to our own research on historical data regarding typical reasons for FDA IND clinical holds.
Again i urge caution in applying generalities, as the particular submission is within a specific field and from a specific company the relevance of the above statement should be apparent if you’ve understood the previously posted link or unfortunately lost out at the hands of Mr95% and his ramp gang.
So i expect the FDA Clinical hold to be made on CMC & Clinical concerns, these being typical reasons for FDA IND clinical holds in this field.
I suspect the FDA requires further evidence on the repeatability of quality manufacturing of the product. Remember Hemo’ have only produced the minimum number of quality runs the submission requires. Yes,i know they were independently certified!
I also suspect the FDA have concerns regarding the clinical aspect and the sufficiency of the toxicology information provided.
See link and explanation of toxicology issues with Car-T in AML trials.
Now the 95% ramp gang will rush to discredit all of the above and try to distract with CBR and other ramping rubbish.
Just remember what I’ve said.
Suggestion.
I’d suggest if the company are confident in resolving the FDA concerns and wish to impart in investors that same confidence, they publish the detailed FDA clinical hold letter they’ll be receiving soon.
To use a topical phrase, if necessary for competition reasons a redacted version would suffice.
Apparently the technology and science involved is all covered with Patents so personally, i see no reason why they can’t do this and will draw my own conclusions if they don’t.
https://www.nature.com/articles/s41375-021-01232-2
AIMO
…TBC. Time lines & other non-FDA concerns.
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