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DragonBear

09/19/19 8:50 AM

#101806 RE: concordia #101788

I believe that is for New Drug Applications and not Investigation Drug Applications

It appears to be for NDAs, and BLAs.

The example of CytoDyn was a waiver for a BLA for a Phase 2 CT. With their drug already fast tracked. They had to prove there was a financial barrier to getting a superior product with no treatment alternatives to market. The fast track status provided that cover.

PMCB is not a real Biotech and none of the Nonsense posted about foundations and partners and buyouts or clinical trials will ever happen



Indeed. Foundations do not fund public biotech companies. They fund academic research as in Universities, and patient resources. There are no biotech partners, or large pharma that are interested in yet another 2nd line chemo treatment using Metronomic chemo. Where potential revenue is very limited. And such a treatment is likely to fail quickly in 2nd line patients. Comical would be for smiling Kenny to announce another Microcrap as a JV partner.

Then again, there's an extremely high probability smiling Kenny will give SHs exactly what he has promised: Generalities about the mythical IND, and mythical pipeline. With the IR screening SH questions, to make sure smiling Kenny gets nothing but nerf balls to field.

All one has to do is read their 10q's to discover the only thing going on here is sell shares at .005 and pay management and friends. 10q reports are not make believe.



In Microcrap scams, it seems PR pumps are more important than Form 10 filings.