Replies to post #54803 on PharmaCyte Biotech Inc (PMCB)

[DragonBear]

PMCB PharmaCyte’s Chief Executive-Scammer

When I started to lead this company in January 2014, my first goal

was to P&D a Microcrap scam.

Pre-IND consultation occurs when the company consults with the FDA as to what data will be required for IND approval. Starting before IND submission. From the FDA site:

Pre-IND advice may be requested for issues related to data needed to support the rationale for testing a drug in humans; the design of nonclinical pharmacology, toxicology, and drug activity studies, including design and potential uses of any proposed treatment studies in animal models; data requirements for an Investigational New Drug (IND) application; initial drug development plans, and regulatory requirements for demonstrating safety and efficacy.

My second goal was to get our therapy to the FDA and with this pre-IND meeting request, we have accomplished this goal as well

No Kenny, you get the therapy to market. And without an IND, there will be no clinical trial. No Phase 1,2,3 clinical trials, no therapy to the market. Asking the FDA what they want to see (e.g. toxicology data missing from the 1999-2001 pseudo-trials) has not accomplished anything.

The beauty of Microcrap biotech scams is they can claim they are in pre-IND discussions, or that they have even submitted an IND, and there is no way to confirm or deny such claims. IND status information is not made available by the FDA. Neither will the FDA confirm or deny a drug company has an IND submission being reviewed.

BTW - by law the FDA must approve, deny, or place on hold any IND within 30 days of submission. Yet Kenny seems to be having problems getting data generated almost 15 yrs ago into a IND submission the past 2 yrs. Wonder why?