PharmaCyte Biotech Inc (PMCB)

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The FDA's Accelerated Approval Program allows for the approval of an investigational drug or treatment based on a surrogate endpoint (a measurement that can "stand in" for an accepted measurement of disease progression) in early-phase studies if the condition is serious or life-threatening, and Pharmacyte should have an excellent case for just such an approval.

If that were to happen, the company may or may not be required to conduct a Phase 3 trial while its treatment is being used by patients with advanced, inoperable pancreatic cancer. It would, however, undergo a Phase 4 or "confirmatory study" to further evaluate and confirm the efficacy and safety of the treatment, but it would do so with Cell-in-a-Box® combined with ifosfamide on the market.

Well, as Dr. Hidalgo, Principal Investigator of PharmaCyte’s trial, says, “If the results are positive, these results may pave the way for an accelerated approval process through one or more avenues afforded by the FDA.”

This post is fact and should be posted daily here on the PMCB board it should also be sticky on the opening page. Anyone that feels they should post it daily please be my guest . This is a fact and was said by the top Pancreatic Doctor in the world that happens to be the PI of our trial and designed it. Dr. Hildgo of the Weil Cornell belives our treatment could treat all solid tumors.