Besides showing how well a drug works, the FDA wil
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Posted On: 04/23/2018 2:03:05 PM
Re: daydreaming2 #44727
Besides showing how well a drug works, the FDA will ask how the drug is produced. There's a section called Chemistry, Manufacturing, and Controls (CMC) in the NDA. If B-OM is granted rolling review, which I expect it will under BTD, IPIX can submit the CMC section for review first.
Today's PR adds value to potential partners because it addressed a necessary step toward approval. I've seen drugs with good efficacy put on hold due to manufacturing issues. So finding a manufacturer that can produce drugs in high quality consistently is crucial.
Today's PR adds value to potential partners because it addressed a necessary step toward approval. I've seen drugs with good efficacy put on hold due to manufacturing issues. So finding a manufacturer that can produce drugs in high quality consistently is crucial.
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But I do like I said I do not think this was the next most important step.
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