They should have the 700mg safety data either way.
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Posted On: 07/20/2019 2:59:14 AM
Re: ClosetInvestor #5069
They should have the 700mg safety data either way. So whatever the FDA decides on 525mg, they should have. I believe it is just a matter of cogs and including the 700mg data into the BLA clinical part. CMO part, not sure, but a big company like Samsung shouldn’t be an issue to add whatever is needed without much delay.
For the mTBNC, I don’t believe we see significant progress until the other sites come online. Yeah, they can inject the first patient, but we need several and the bigger sites is key imo.
For Adam F. I agree. Not an issue. I’ve read several of his pieces trading other stock where he did a hit job. The guy is clueless, like saying before 81% with Combo unmet need was disappointing. He had no clue that was twice as good as others which had been approved in that area. (I find it curious almost all of the 19% failures were in the placebo arm). The implication though of what they were trying to accomplish by including him is irritating.
For the mTBNC, I don’t believe we see significant progress until the other sites come online. Yeah, they can inject the first patient, but we need several and the bigger sites is key imo.
For Adam F. I agree. Not an issue. I’ve read several of his pieces trading other stock where he did a hit job. The guy is clueless, like saying before 81% with Combo unmet need was disappointing. He had no clue that was twice as good as others which had been approved in that area. (I find it curious almost all of the 19% failures were in the placebo arm). The implication though of what they were trying to accomplish by including him is irritating.
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