Thursday, May 05, 2016 1:49:11 PM
1. Unprecedented
2. "The Company is in ongoing dialog with regulators, and providing further information." -- NWBIO
Guesses:
1. If one were to guess that further information was separate and apart from information originally supplied back in September, I suppose one could speculate the second interim was recently reached -- Koman believes first interim likely occurred by or before August.
What other information in addition to or in lieu of normal trial data could NWBO be providing to regulators?
2. I suppose one might speculate it could be updated progression analysis under new guidelines that Dr. Padzur found critical to obtaining cutting edge information on whether or not a response to therapy might be occurring by correctly assessing PFS.
3. Senti has proposed a guess that it might have something to do with being asked by the regulators to have deep sequencing done by Adaptive Biotechnologies on all the tumor samples.
4. One might also ask what is the least mature data in any potential material provided to regulators, and I would suspect that would be patient data from the Expanded Access Program. I suppose this would be more data on rapid progressors and pseudoprogressors. psPD data might be particularly important if these patients are likely (IMHO) primarily mesenchymal + high TIL count. It's also possible the regulators really want to see if the rapid progressors are still managing to demonstrate increased survival in a group separate and apart from the information group. The expanded access program was started May of 2014, so we are now 2 years into that program. This might be enough to get a trend on the rapid progressive patients if the information arm before them is any guide (see info arm data below). Particularly if there was a backlog of patients that entered the expanded access arm at the same time.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
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