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Sunday, August 23, 2015 10:25:48 AM
Note for others: The 190 enrollment figure thrown around back in 2013/2014 came from Pyrr who stated it was in the (old) protocol, and the resizing analysis was triggered by hitting that number. It apparently hit about the same time (within 2-3 months) as the 66 events. No one knows if this is correct, not even Pyrr, because no one truly knows exactly when the resizing analysis started and whether it was triggered by 190 enrollment. IMHO, it was not a blind guess, but was a ballpark educated guess.
Note: Many theories have been laid out over the last 72 hours here and on YMB. If you are new to this stock, it will take you considerable time to sift through years of information to know if any are reasonable. Still, if you are investing, the best resources are SmithonStocks, the introduction page on this ihub message board, NWBIO.com, SEC filings, agency rules and guidelines, DMC guidelines, CRO methods and hundreds of research articles referenced there and elsewhere on dendritic and related technologies.
This DCVax-L trial has a long history. It is a technology that had to be proven safe over a very long period of time because it basically relies upon our own immune system to attack the right antigens, because we are pulsing the dendritic cell with ALL the tumor antigens. The fear way back when was related to autoimmune responses/side effects. That fear has been proven unwarranted. The therapy also creates a long tail of survival, so a slow moving trial makes this a fair trial. Even the FDA recognizes this in cases where there is a long tail effect. This trial is built for accelerated approval. I recently posted a real world example of how that might work in coordination with FDA as it relates to rolling review for AA. This trial has orphan status, which makes close coordination with the FDA much easier. The closest conference coming up is in the middle of September. The lead sponsor is NWBO, and it features three opportunities to hear from NWBO in different settings. The next conference NWBO is attending is the SITC annual conference in early November.
I have rarely seen so much fear and disinformation from shorts to attack an as yet undisclosed 1st interim IA (1st interim IAs are normally innocuous) which may or may not yet have already occurred. We all make mistakes, and this board is supposed to facilitate discussion, but at times like these, any sincere discussion is often buried by insincere voluminous disinformation.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
Recent NWBO News
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- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 09:11:16 PM
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