Ok, a few comments echoing many thoughts that various posters have expressed - and maybe a few new ideas.
1. Until this morning (though several folks have been providing hints to the contrary and the ESMO notice had apparently confirmed that reasons for optimism were real), the Sunrise trial had been halted and was an unmitigated disaster.
2. As of this morning, we were treated to the news that subset analysis utilizing biomarkers had yielded statistically significant results in a certain unidentified subset. What wasn't provided was the nature of the subset or the magnitude of the improvement observed. Kind of funny to watch the various spins and conjecture on this "teaser".
Now to what might be some new thoughts.
1. A Proffered Paper at the prestigious ESMO. I won't go into the positives of this because others have already discussed it. My additional slant is that I like how PPHM's relatively new PR firm managed to pre-sell PPHM's involvement in this conference and offer a "teaser" to generate interest. I like this very much. I've been critical of PPHM in the past due to their lack of salesmanship as well as their lack of "big time" deal making help. This isn't a secret as the guys at PPHM are tired of hearing me gripe. So, I view this "teaser" as a very welcomed move.
2. I mentioned above how the Sunrise halt had been a killer. However, what people may not realize is that the halt allowed PPHM to immediately un-blind the data and start the biomarker/subset analysis. Without the stop, we wouldn't have the data they're hinting at today and we wouldn't be going to the ESMO. So, blessing in disguise? I think so.
3. So what happens if the data is compelling? Is it back to Phase I or I/II as some have suggested? Or, are we filing a BLA as others have suggested? I'm in between. If I'm the FDA, I want to press forward with treatments. I have compelling data from a certified Phase III trial - so it's "real" data. Subset analysis of trial data has generated compelling results. Is this enough for approval? I think not. But, I like the data. So, how about a properly sized (meaning small), confirmation trial to confirm the data? I bet Garnick is already talking about what will be required with the FDA.
4. Finally, I have to agree with several posters and I've been fairly stunned that the exosome news didn't even ripple the waters. Early detection, blood tests, biomarkers, etc. are the holy grail. PPHM seems to be headed in the right direction. Yet people want to talk about trading patterns. Note to the board. The amount of money required to walk PPHM stock around is minuscule in the world of trading. Concentrate on the clinical developments and what potential partners are doing.
5. As I mentioned above, I've been critical of PPHM's deal-making efforts/expertise. It's no secret that I didn't want to go it alone in phase III. And, I wanted to deal-make at a top level. The party line in responding to my criticism has always been that the BP world doesn't yet buy the PS MOA story. Word to PPHM has been, "show me". BP's have wanted PPHM to provide actual human data before real deals can be done. I've never bought into that argument, but that's an aside. But, what today's PR seems to indicate is that PPHM is now in possession of proof that Bavi works - at least in a certain subset of nsclc patients. And, the appropriate universe of responders can be identified with biomarker analysis. So, is the data compelling enough to bring BP to the table? I have a good feeling that it's finally "game on". And, like I pointed out above, we wouldn't be here at this point if Sunrise hadn't failed. How ironic.
Like Ex, I'm always a bit skeptical before I see the results in black and white. So, I'm going to reserve judgement. But, I'm very much looking forward to the ESMO.
Regards,
WH
