Replies to post #75789 on PharmaCyte Biotech Inc (PMCB)

[Triple9]

Yes, absolutely. Phase 2b is what the FDA said in the pre-IND meeting.

Info on how a phase 2b is different from a phase 2 and how the "pivot" works:

"Using decision theory, Gilbert outlines how to effectively surmise one of five decisions at the end of a phase 2B trial: (i) treatment is harmful, (ii) treatment is useless, (iii) treatment is plausible and a phase 3 trial should be conducted, (iv) treatment meets phase 3 criteria for efficacy, or (v) treatment meets criteria for efficacy from two phase 3 trials.

The decision theory framework is the mathematical formula that allows the study team to place weights as to the importance of each of the above five concepts in determining a study outcome while still arriving at a single decision on the basis of the size of the effect of the treatment in the study. This makes decision theory no more difficult to interpret than interpreting a P value above or below 0.05. Using this study design framework, Gilbert theorizes that moving to a phase 3 study from a phase 2 study is only warranted when the pre-test plausibility of treatment success is extremely high. This work establishes the role that phase 2B studies can play in moving more treatments from the bench to final clinical testing in humans and shows how decision theory can be used to expand the considerations included in a studies design."

from Phase 2B Clinical Trials—A Useful Interim Step to a Phase 3 Clinical Trial

http://stm.sciencemag.org/content/2/31/31ec76

[1234jklm]

Everything but cells is ready for pivotal ind

Thank you for your email and for your interest in PharmaCyte Biotech. No, the MCB and the WCB are not complete. Once the cell banks are ready, cells will be shipped to Austrianova to encapsulate and to test, and the information generated from each of these steps is what is left to be done to file the IND. PharmaCyte is not currently planning to announce the completion of the cell banks and the company can not give an IND submission date until this work is complete. When the IND is submitted, PharmaCyte will likely make this announcement.