I am not sure. I agree with misiu that if results are good, approval will be fast, but I’m not sure how fast? Other than learn the FDA and BLA process, that is somewhat why I was trying to figure out if TNBC would be a sBLA? If so, then everything hinges on combo approval. Misiu is much more knowledgeable with all the science stuff and thinks it may be approved before combo even.....and I do also depending on what approval options the FDA has. I would think that if a drug is badly needed for such indications that they would approve ASAP regardless of the technical filing processes.....but then again maybe that is the entire point of having the expanded access program?
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