Yeah, I understand. There has been many things ac
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Posted On: 07/02/2019 4:22:06 PM
Re: Evil Rabbit #4486
Yeah, I understand. There has been many things accomplished over the last 6 months, but the milestone timelines being missed gives the impression nothing is being done. What really hurt was the BLA getting pushed back for 700mg safety data, if that hadn't happened, there would be a complete different vibe right now.
For the BLA, Part 2, is just waiting on the safety data. Its been 22 weeks since the PR saying the FDA wanted 100 on 700mg. They had 74 on 700mg then. So even if the FDA still wants 700mg, that should be done I feel end of August (enroll the additional 30 in February + 24 weeks).
Part 3, The CMO part was my biggest concern before the Samsung deal. That is the most complicated and having Samsung already with FDA approval with mabs removes my concern. It wasn't a concern that it would ultimately get approved, but just delay concerns from failed tedious inspections from a lower level CMO..
For the BLA, Part 2, is just waiting on the safety data. Its been 22 weeks since the PR saying the FDA wanted 100 on 700mg. They had 74 on 700mg then. So even if the FDA still wants 700mg, that should be done I feel end of August (enroll the additional 30 in February + 24 weeks).
Part 3, The CMO part was my biggest concern before the Samsung deal. That is the most complicated and having Samsung already with FDA approval with mabs removes my concern. It wasn't a concern that it would ultimately get approved, but just delay concerns from failed tedious inspections from a lower level CMO..
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