Paul, if PPHM were to run Bavi Phase 3 study on their own, it would be after the FDA has reviewed and approved protocol. The go it alone path needs to remain viable for PPHM to carry indepence during Pharma partnering negotiations, even if there are competing Pharma in negotiations.
The terms of the loan provide enough time for a Phase 3 trial to reach completion. However, the PPHM burn rate for normal operations are only covered if Avid revenues are boosted way up or PPHM goes back to means like the ATM for funding while Phase 3 Bavi trials proceed. Going it alone "kind of sort of" is coming into focus as a viable PPHM option. However, a properly negotiated "win-win" deal with a Pharma with enough cash on hand to support trial and PPHM operational funding needs for two or three years still is more appealing. The longer an interested Pharma waits for signing onto a deal with PPHM, the more PPHM management will be compelled to take on the downside for setting up to go it alone, leaving the gap between the desired Pharma bid price and PPHM ask price getting larger. Success in Phase 3 trial launch set up and FDA approvals positions PPHM so that they don't need a Pharma deal as much and Pharma should expect to need to offer a larger bid price for PPHM technology.
The PPHM financing being squared away makes it likely that PPHM can go it alone at least through the point of trial design and FDA Phase 3 trial approval. As Adam Fuerstein wrote in his column Qand A, he hasn't seen data yet that convinces him Bavi works. Pharma who signed confidentiality agreements with PPHM should have. AF and all of the PPHM investor pool should see such data by the end of next week, within the boundaries of what can be shared from trial arms that may not have reached ripeness for Median Overall Survival reporting. Let's call next week's news a prospective PPHM pps inflection point....
Best wishes and IMO.
KT
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