My post for today.
Finally penciled it out last night as well, and think/agree 248 events (if I'm even close to knowing enrollment at this time) would push us out to late 2016 -- at least -- (198 events is significantly faster to acheive with full enrollment.) Not so certain we will hear anything at all if 1st interim is a DMC halt for efficacy recommendation with NWBO continuance, but the longer silence continues, the more chance a halt for overwhelming efficacy recommendation occurred and NWBO quietly continued. The Pyrrs and large investment institutions of this world will be using their "parallel processors" (if you will), and their internal confidence/investments will follow. In other words, I guess I think excessive talk of an actual halt by NWBO prior to completion may be a distraction, and we simply accept LP's desire to keep this trial from stumbling. That said, this is an orphan case, and communications with the FDA are supposed to be a bit more collaborative. I guess I mildly disagree that a DMC halt recommendation followed by NWBO continuance would be PRd in any way. While the trial remains blinded, these types of hints are strictly verboten.
Regarding L:
Thus, for me, it's best to assume silence in the second quarter means surging investment in the third quarter. NWBOS's self-discipline will be a plus with large investment firms.
Conclusion: L covertly drives price.
Regarding Direct:
These trials will be spellbinding to watch, and if phase II (highly improved) trials translate to significantly faster (and even better) results than phase I, look for investment money to pour in for:
* phase II trials in other indications,
*accelerated "end-to-end" automation manufacturing capability (need to treat this like gearing up for WWII -- except we are fighting cancer.)
and if it hasn't happened by then,
*3/4 or 4/4 FDA fast track designations for inoperable cancers within each phase II indication -- "breakthrough therapy" "accelerated approval" "orphan designation" "priority review."
(Note: Keytruda received all these, and it is inferior to Direct)
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
