Exwannabe, Do you know how far along discussions have gone with the FDA regarding design review and approval for a Phase 3 trial? We have seen from PPHM call notes that PPHM expects to be discussing Phase 3 trial design approval this Fall, with or without a partner, preferably with a partner. The Phase 2 was said by Dr. Garnick to have been designed with Phase 3 type deliverables in mind, prospectively streamlining Phase 3 design progress and setting up a foundation for prospective Advanced Approval.
Yes, time needed for recruitment and implementation of a trial that might involve documentation of Median Overall Survival measured in years rather than months can breach the timing of the loan payback terms, calling on PPHM to come up with other funding sources. The new financing is structured to let PPHM get that second tranche only if the FDA Phase 3 trial approval has been achieved and the trial gets underway. Exercising of that path is something PPHM has indicated they would rather do with a partner, but if Pharma prospects are holding out, PPHM does have a path to keep things moving on their own. Serious Pharma partner finalization negotiations should be underway going into this Fall.
Best wishes and IMO.
KT
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