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Tuesday, November 03, 2020 2:54:41 AM
I still think waggs will get IND over finish line...fda has asked for more info and pmcb will provide it..
One cannot possibly provide what data one does not have. It is highly unlikely that the FDA is just requiring answers to the cells used or the encapsulation of them.
FDA always requires SOUND data. Verifiable data is needed so that they can determine if this testing is warranted or not warranted. If one cannot provide such data regardless of status (orphan drug) the FDA will shut it down. The FDA is not a joke agency like the SEC. When it comes to things like this they require the goods.
scam
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