Geo, I agree with your points, just as I am calling out how a potential Pharma partner is on a constrained timeline for procrastination to sign the right deal with PPHM. If it doesn't happen soon (by year end?), PPHM needs to start the Phase 3 train out of the Station without any Pharma on board. Why? PPHM found out around September 21 that at least one Pharma that was peeking at their tech via confidentiality agreements was launching "me too" trials that would have been initiated with research right about the time the Bavi trial CRO intentional miscoding occurred. The PS target is superior, per reported trial results at ASCO. Yet, if a Pharma head fakes PPHM into delaying a trial launch too long after PPHM received a FDA Phase 3 trial design approval, PPHM starts to become inconsequential, good tech or not. PPHM can't afford to let that happen. PPHM management knows that. Hence, it won't be allowed to happen. We can count on that, post September 24, methinks.
I am of the opinion that, if PPHM doesn't have a partner set to announce soon, going it alone becomes a PPHM survival necessity. Further, if PPHM is compelled to absorb the down side of launching the trial alone, scrounging for needed resource without a partner, Pharma partner value drops to null. . PPHM would have incurred the hits imposed to raise the funds before a partner tries to step in to share in the fruits of PPHM's labors.
As I posted earlier, PPHM can contract out for distribution services until they build up their own. If PPHM is becoming a big Pharma by its own right, they will attract the talent that jumps ship from the competing Pharma that maneuvered themselves to be left with nothing. In an earlier post, I laid out three options that all presume that PPHM is proceeding with a Phase 3 Bavi trial without delay, with or without a partner.
Option 1: PPHM goes it alone with the trial start and Bavi tech delivering on its potential brings interim results sufficient for an advanced FDA approval about 18 months from trial start (ball park timing).
Option 2: PPHM goes it alone with the trial start and the Partner catches up when they decide they are ready to lay out funding commensurate with what PPHM management/investors expect.
Option 3: PPHM starts the Phase 3 trial with a newly announced partner in timing with close proximity to ASCO, first line MOS results announcement and Russell rebalancing etc. .
PPHM raising $60 million over two years with Bavi trial data coming in so positively is quite doable. Plus FDA Phase 3 trial approval already having been achieved means that Pharma partner prospects are close to having overplayed their hands. If there is a Pharma sincerely interested in partnering for PPHM tech, we should see an announcement soon. PPHM may find the need to launch alone to draw out a partner, but once that happens, what is left for a partner to contribute beyond a sales force that PPHM could contract for from the Pharma's competitors or contract sales services?
I know unemployed Pharma reps who were the victims of their employers overplaying the value of their product as it was going off patent protection and vulnerable to generics. There are parallels between the Pharma sales force implosion over the last few years and what happened with private brokerages when investors realized they could post their own trades. The days of a sales force army pushing a Pharma product onto prescribing doctors is a relic of the past. As Bavi demonstrates it works, the prescribing doctors will be calling PPHM to learn how they can bring Bavi to their patients, pulling PPHM to expand deliveries. Improving Median Overall Survival over all alternatives is a big demand pull.
I keep in mind that it is doctors who prescribe treatment for patients, not Pharma that want to ace out competition. Ultimately, doctors know that they have the prescribing authority and will do right by their patients. Venues like ASCO help doctors find their way to best treatment options and ASCO doctors saw Bavi results.
Best wishes and IMO.
KT
