Ergo, the only way to get a clear answer would be

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Ergo, the only way to get a clear answer would be from the FDA communications.

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FOIA requests rarely provide "clear answers". And if you have six months to wait for a response, then have at it. By the time you get a response to a FOIA request to the FDA, the BLA will have been submitted and probably approved, so it will be a moot point by then.

Just fyi, I've worked with FOIA requests and I'm very familiar with how long they can take to process.

My comments are just my opinions and should NOT be taken as investment advice.