Oh dear Haywire , look what you’ve gone and dragged up !9 Jul 2025 07:43
1/2.
Out yesterday with no opportunity to respond.
Haywire, I see you didn’t actually find ANY inaccuracies in my previous post as i challenged!
instead and again, simply resorting to distraction from the question, as is your M.O.
Response.
Within your failed distractive attempt to discredit me, you’ve dug up the previous debate regarding the clinical hold in the IND where you claim, i was incorrect…really !?
Actually, i was proven correct in predicting the CH and pretty much the only one who called it . After the CH announcement, at interview, even Vlad expressed that it was quite normal in the process. Paraphrased.
So let’s be clear, i was correct and shared the same view as Vlad, whilst the ramp crew here were proven very wrong as are you, right now!
To the meat of the recent debate.
You and others here, have either by implied inference or directly stated that;
The Pediatric expansion announced October 2024 could ONLY be granted approval following “staggering” (as one describes) Efficacy, demonstrated within adult P1 and possibly P2 treatment.
Whereas, i maintain the clinical trial and IND application detail, considered along with zero reportable safety events in adult treatment to date, could likely be sufficient for the FDA to consider risk/reward as you describe, and issue the required paediatric approval.
So who’s correct ………guess what ?
Mr AI agrees with me and not you,the scientist!
“An extension to a pediatric cohort within an existing adult clinical trial can be approved following satisfactory safety signals, but demonstration of efficacy is also a crucial factor, though NOT always a prerequisite for approval.”
Haywire, you must learn…posts with questionable inference are unwelcome, especially from a scientist!
AIMO
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