So honestly speaking, what could prevent us from F

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So honestly speaking, what could prevent us from FDA Approval?

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There is nothing that will stop us from FDA approval. However they could jack us around by delaying things. They may say we need to reformat the data or want more for the CMC (even though we're already approved with our initial manufacturer for clinical drugs). There are many ways they could screw us over and at the same time bootlick BP.