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Then the FDA should be continuing to review our BLA as we gather the requested additional information, correct? They don’t just put it on the back shelf and say when you have it all we will review it.

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No offense intended, but I think you are dreaming:

Source Link: https://www.fda.gov/media/78941/download

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A refusal-to-file decision ends the review process. The applicant’s options are to resubmit the NDA/BLA with the deficiencies addressed (the resubmission is considered an original new application) or to request that the NDA/BLA be filed over protest. PDUFA V “Program” applications that are subsequently filed over protest are removed from “The Program” and become subject to the standard 6- or 10- month review clock, as applicable. The applicant must be notified of a refusal-to-file decision (via RTF letter) within 60 days after the original receipt date of the application.

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So, no, they do NOT continue to review our BLA. I'm also not sure if the standard 6 or 10 month review clock is reset to zero.

Regarding other statements, respectfully, I'm not sure you are fully appreciating the influence Big Pharma exerts on myriad related industries and regulatory bodies, and I'll leave it at that.