Now I don't want to dwell on the negative, but I must say that having the control arm of the Sunrise trial "dramatically" outperform is disconcerting to say the least.
To put things in perspective, had the control arm outperformed similarly in other trials, we would have no IO drugs approved to date, or put another way, had the control arm performed as per historical norms, Bavi would be heading for approval and the share price would be $5...$10...who knows? Of course had the ph 2 trial not been tampered with, there is a good chance that Bavi would be the first IO candidate heading for approval, and current SOC would be Bavi and Chemo, and our share price would be??...$50 or $100?.....and who knows, Opdivo and Keytruda may not have ever been approved?
So we are talking about BP losing hundreds of billions of dollars here....so you see, the stakes are very high.
Now back to the Sunrise control arm....why did it dramatically outperform?
Well we may never know for sure, but one certainly can not rule out trial design, enrollment criteria, and choice and location of enrollment facilities. We are not talking about Bavi's performance...we are talking control arm only.
Dr Garnick, Dr Menander, Dr Shan, Steve King, and the others involved in the Sunrise trial design must be looking at this. True, Opdivo and Keytruda were not yet approved at the start of trial design, but they certainly would have been aware of these IO candidates that were showing good trial results and probably heading for approval. If in fact the reason the control arm outperformed, is because the Oncologists were recommending to their non-responder patients to give Opdivo a go, and they consequently responded to treatment which skewed the control arm survival numbers to "dramatically" outperform......well should our esteemed team not have thought of this beforehand???
Was the subset enrollment criteria flawed??...too many enrollees from the US south, or north, or Europe or, perhaps it was the Mediterranean diet that sustained so many of the control arm enrollees?? (apparently there were/are subsets of Bavi patients who did/are doing very well...fwiw)
How does the FDA look at this? Do they shake their head and say...wow, too bad for the folks at PPHM...did you see that outperformance of the control arm?? Wow, that was weird!
So what does it all mean?? Does it mean that BP always wins and somehow ensures that upstarts never make it to the playground?
Was the trial design flawed? Was it intentionally flawed?(oops!)
Can the FDA really ignore such a control arm outperformance, and thus keeping what may be an efficacious and safe drug off the market?
I would hope our BOD and legal council would be taking a hard look at all of this.
Finally to all of the naysayers....yes PPHM is down but definitely not out. Avid 1, 2 and probably 3 will sustain the company and again let the share price recover. Bavituximab will be approved at one point as a combo drug, but not sure exactly when....maybe when the BP's allow it?? lol
In my opinion, selling here makes no sense. I think Avid alone can take us to the $3 to $5 range within a year or two. And Bavi and Betabodies and their other Mabs are being extensively tested at NCCN, UTSW and MSK....with current Biomarker testing, results of efficacy come much quicker...we may yet hit a homerun in Oncology or Viral.....so hang around for Avid, and cross your fingers that Bavi or BB's or other mabs hit on some indication in the upcoming trials.
As for the FDA, they have to start looking hard when control arms dramatically outperform, and if I were Garnick, I would be pressing them very hard right now!
All IMO.
