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.

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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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