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But the third party auditors were not done working on all of the Amarex crap. Long story short, the auditors were able to validate the RAW DATA. This is the data that is cloected by clinicians that interface with the patients collect and eventually put into the electronic files. The CRO does not do that.

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The CRO or pharma company (if directly running the trial) are responsible for validating data. Do you think the FDA accepts un-validated data. Validating tens or hundreds of thousands of points of data across over six hundred patients would have astronomical costs and a very long timeline. Almost certainly the companies hired to review feasibility looked to see if the data existed at the clinics and what the cost of recovery, validation and BLA submittal would be.

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IMO and other familiar with BLA filings that the majority of the documents and other documents CYDY was working on are for passing a BLA submission audit. We HAVE NO DOUBTS ABOUT THAT. The clinical hold will be lifted and we feel based on experience that a BLA resubmission will happen at a minimum.

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Time will tell won't it.

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The FDA had the UNUSUAL PDUFA-likje panel meeting. The only thing different about that meeting is: it was not public (PDUFA meetings are public) and there was not vote of yes or no...as far as we know.

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I'm not sure which meeting you are talking about. If it's a meeting about the BLA submission between the FDA and the Sponsor they're not public. If it's internal FDA meetings to review the final decision on a BLA submission they're not public either. If it's a meeting about the safety hold being lifted or a possible BLA resubmission those are an FDA/Sponor meeting and are also not public.