hI @col69,
yes, industry sees the future.
But the FDA is still playing catch-up e.g. the swathe of new Guidances on cell and gene therapies over the last 2 years. And they're holding that line for us & we're right there at the head of the queue.
See, for example, the CRL they chucked to Abeona Therapeutics on Monday night for the company’s BLA for prademagene zamikeracel (pz-cel), which is a cell-based therapy under development for treatment of recessive dystrophic epidermolysis bullosa, a rare disease. No favours though. The CEO insists that the CRL says nothing about efficacy or safety but their PLI had a list of the dreaded "observations".
Cheers
GLTA(LT)H
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