Where Techinvestor was talking about Osiris vs MSB patents, he was meaning the two different MSB products. Remestemcel is the Osiris product. Rexlemestrocel is the MSB product.
ODAC notes only apply to Remestemcel.
"Perhaps we better insist on seeing a rock solid potency assay before not after granting a BLA with a phase 4 to confirm?"
I don't think so, remember the MAP scores and efficacy of nearly 70% survival vs 20 % outweighs the potential negatives here. That is a massive benefit, and the fact is to pproove it will take years 3 or 4. That is 3 or 4 years of children dying in the persuit of a better P value. Do you really think demanding another phase 3, and then another phase 4 is considering the unmet need and high mortality rate ?
"Wouldn't you think (in the FDA shoes) that when MSB comes to need more Donor Cell Banks to be generated beyond those they'd already had at 13 August 2020, that perhaps they'll go with a potency assay on new DCB's that isn't really good enough on the assumption that hey the product is nonetheless safe even if we aren't sure that its potent? And perhaps because they may have business pressures to ship product to get revenue"
Not now that they have re-done the potency assay.
I can see the FDA having a hard time not approving the product if the TNFR1 and your theory about the recombinants causing the assay to be confounded. It will only mean one thing.... even higher relationship between potency assay testing and patient outcomes, and that is what the company said they have in hand now. It will be a fantastic day for the parents of srAGvHD sufferers , when they realise the odds of survival for the most likely to die, have moved from 20% to near 70%.
MSB Price at posting:
91.5¢ Sentiment: Buy Disclosure: Held
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