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Re: Big Tom7 post# 141008

Monday, 04/05/2021 11:46:51 AM

Monday, April 05, 2021 11:46:51 AM

Post# of 144814
Why would the FDA entertain a scam?

The FDA doesn't judge business models.

Outside of eye-of-newt to cure Covid, the FDA will review anything "reasonable" submitted to them.

The FDA also can not predict the plans of a biotech/Pharma. PMCB is not going to get a Phase 2b CT approved. However, maybe some year Kenny will start at Phase 1. And when that fails using PFS as an endpt, then Kenny might be able to switch to a trial for palliative treatment. Which is difficult to get marketing approval for in this instance. In any case the pre-clinical tests required for a Phase 1, or palliative treatment CT, would be the same as they are today. Or Kenny may have already decided he'll just PR pump for another 2 yrs, and then walk away. In all scenarios the FDA isn't in the business of predicting what future direction a company might take with its proposed treatment. Instead the FDA tells the company of any pre-clinical and/or protocol deficiencies in a submitted IND. There's nothing to "entertain".

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