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Posted On: 12/12/2019 3:31:50 PM
Post# of 148936
Re: craigakess #12574
This drug should be a cautionary tale for CYDY management. Safe, generally effective... and delayed for at least a year due to deficiencies in the manufacturing facilities and processes. I.e. the CMC portion of the BLA. I'm intimately familiar with the CLR, for all the wrong reasons.
https://www.immunomedics.com/our-company/news...plication/
It's exactly why I harp on the need for CYDY to get the BLA right , and not just the need to get it in. I would feel better about this if Samsung were the sole manufacturer at this point. Signing a commercialization deal with a major - I'll count "mid-tier" - pharma prior to the BLA submission would also make me feel much better, as then an experienced company would also have a vested interest in getting the submission correct the first time.
Hopefully the FDA stops twiddling its thumbs and holding up drugs that may help very ill patients over procedural details, but I'm not counting on that.
https://www.immunomedics.com/our-company/news...plication/
It's exactly why I harp on the need for CYDY to get the BLA right , and not just the need to get it in. I would feel better about this if Samsung were the sole manufacturer at this point. Signing a commercialization deal with a major - I'll count "mid-tier" - pharma prior to the BLA submission would also make me feel much better, as then an experienced company would also have a vested interest in getting the submission correct the first time.
Hopefully the FDA stops twiddling its thumbs and holding up drugs that may help very ill patients over procedural details, but I'm not counting on that.
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