Agreed. Not going to dig up my old research to ci
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Posted On: 04/24/2020 9:56:10 AM
Agreed. Not going to dig up my old research to cite, but something like 90% of drugs that have a BLA accepted by the FDA eventually get approved. About 90% of that unlucky one 10% are due to safety concerns. Our chances of eventual approval are therefore close to 100% in my book.
However, that doesn’t necessarily mean it’s a lock on this submission. I agree with CDiddy that we’re in good shape with the FDA holding our hands on the preclinical - which they’ve already had months to review - and the clinical - where they’ve spent months dictating to the company exactly what they want to see. CMC is trickier and can be problematic. See IMMU’s drug that got approved this week, almost 16 months after its initial CRL for CMC deficiencies. I feel that having large, established producers on our team (AGC, Samsung) is a huge help, but things can still go wrong. Company needs to nail that one.
Overall, I’d handicap odds of approval sometime late summer or early fall as being quite high.
However, that doesn’t necessarily mean it’s a lock on this submission. I agree with CDiddy that we’re in good shape with the FDA holding our hands on the preclinical - which they’ve already had months to review - and the clinical - where they’ve spent months dictating to the company exactly what they want to see. CMC is trickier and can be problematic. See IMMU’s drug that got approved this week, almost 16 months after its initial CRL for CMC deficiencies. I feel that having large, established producers on our team (AGC, Samsung) is a huge help, but things can still go wrong. Company needs to nail that one.
Overall, I’d handicap odds of approval sometime late summer or early fall as being quite high.
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