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volgoat

09/06/13 11:12 AM

#139189 RE: Carboat #139188

I fully expect them to start the trial alone.
Don't think many retail will be flushed out of it though.
Only question after, is it Roche or Sanofi?

That's all it boils down to now.
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keep_trying

09/06/13 12:11 PM

#139208 RE: Carboat #139188

Carboat, PPHM starting the Bavi Phase 3 trial is the positive event. Whether that activity is supported with a partner or by hardship funding while PPHM proceeds with the trial going it alone is a separate matter. My own view is that PPHM's achievement of 50 trial sites world wide to support the Phase 2 NSCLC trial's 120 patient size places at least a start of the Phase 3 trial while going it alone as feasible, albeit a less than optimized development.

I agree with the directional point you make about importance of a BD, AA or partner being achieved, but PPHM isn't really in an "it all hinges on" situation here. If no Pharma partner candidate is willing to ante up terms in negotiations with PPHM that reasonably reflect Bavi and the anti-PS family technology value, the imputed downside you are indicating will occur as a consequence of PPHM going it alone will already have been rooted into prospective future value to long investors from Bavi commercial approval by the FDA through the substandard terms imposed through a hardship partnering agreement.

In contrast, if PPHM chooses to go it alone rather than accepting substandard terms under a hardship partnering, the upside potential for PPHM investors remains intact, just as PPHM must then incur further challenges by needing to jump all the hurdles involved with doing a Phase 3 trial that a well funded and experienced partner might enable PPHM to avoid. This is the stuff from which a "fair deal" needs to be extracted (fair sharing of benefits, fair provisions for avoidance of risk and hardship)) or PPHM is compelled to go it alone. Again, either way, Bavi gets to move into a Phase 3 trial that can lead to an FDA commercial approval.

Best wishes and IMO.
KT