RE: FDA ref to tech transfer1 Apr 2026 14:33
ABH. It makes every sense?
The transfer was not a change in HOW the CAR-T was manufactured simply WHO. Prior to RFK, Trump and Musks Doge insanity manufacturing costs at CDMOs like Made was 100s of thousands per patient. Thanks to the insanity of the past few years manufacturers like Made had surplus capacity and costs were slashed, not reduced, slashed. To maintain manufacturing capacity Hemogenyx would have annual deep cleaning bills and shutdowns of their GMP certified labs, they had 14-15 staff I believe? MOST necessary for manufacturing and running the trials, they had a bottleneck in terms of clean room capacity, they held the CMO authorisation title from the FDA restricting attractiveness of Big Pharma who would certainly NOT want to licence HG-CT-1 and become beholden to Hemo to acutally manufacture.
The cost per patient for P1, P2, P3 if you include time wages certification, rates, rent, everything? Could have been 1m+
The move absolutely 100% was the right move and doing it when they did saved the company, Vlad without question did the right thing.
Holding on to manufactoring capability would have bankrupt the company and you would be sitting at a company with suspended trading not fully funded and about to restart trials not only with cohort 2 but children as well.
As for the grant?? The grant is equipment, supplies, guidance, support, everything you need to do a transfer to Made. But none of this changes the fact, nor does it matter, they already were using G-REX. But that is completely and utterly irrelevant at this point tbh, what matters is the trial is back on, strap in girls and boys!
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