Saturday, October 24, 2020 4:55:44 PM
Senti thank you for this and your many contributions over the years to this board.
Minor note on the Dendreon comment. The company lost the 2007 battle not because of alpha spend but because they were seeking approval on 2 small trials (just over 200 patients) when they had a larger 500 patient trial ongoing. Since 4 members of that infamous ADCom panel voted no on efficacy (13-4 vote in favor, which led to death threats and all kinds of other drama -- look it up if you want to read a good story), it made some sense to not cut the knees out from the ongoing trial and wait for the results.
A couple years later alpha spend did play a big role when the company used alpha for an interim look, which was unsuccessful and nearly cost the final look its success. Of course that final approval success was torpedoed by poor execution in manufacturing and marketing and the company imploded, but importantly I believe for DCVAX-L, Provenge's efficacy has continued to accumulate data demonstrating that despite failure to curb progression, overall survival is extended.
After losing my father to prostate cancer at 55 in 1996 I became a true card-carrying Dendreonite, and by selling half of my stake up near $50 a share (should have sold all, live and learn) in 2010 I bought my first small stake in NWBO and haven't sold a share, and adding bigly in the sub .20 cent range. The DNDN boards back then rivaled this one, and included AVII.
I wonder, since you mentioned AVII recently, what your thoughts are on his model and skepticism, which if I remember correctly were based on the cherry-picked enrollment criteria and apples to oranges comparisons to historical trial data, which with the changed endpoints in the EU becomes even more relevant. I have followed AVII on several drugs and have learned to blow off his opinions at my own peril. TIA
Minor note on the Dendreon comment. The company lost the 2007 battle not because of alpha spend but because they were seeking approval on 2 small trials (just over 200 patients) when they had a larger 500 patient trial ongoing. Since 4 members of that infamous ADCom panel voted no on efficacy (13-4 vote in favor, which led to death threats and all kinds of other drama -- look it up if you want to read a good story), it made some sense to not cut the knees out from the ongoing trial and wait for the results.
A couple years later alpha spend did play a big role when the company used alpha for an interim look, which was unsuccessful and nearly cost the final look its success. Of course that final approval success was torpedoed by poor execution in manufacturing and marketing and the company imploded, but importantly I believe for DCVAX-L, Provenge's efficacy has continued to accumulate data demonstrating that despite failure to curb progression, overall survival is extended.
After losing my father to prostate cancer at 55 in 1996 I became a true card-carrying Dendreonite, and by selling half of my stake up near $50 a share (should have sold all, live and learn) in 2010 I bought my first small stake in NWBO and haven't sold a share, and adding bigly in the sub .20 cent range. The DNDN boards back then rivaled this one, and included AVII.
I wonder, since you mentioned AVII recently, what your thoughts are on his model and skepticism, which if I remember correctly were based on the cherry-picked enrollment criteria and apples to oranges comparisons to historical trial data, which with the changed endpoints in the EU becomes even more relevant. I have followed AVII on several drugs and have learned to blow off his opinions at my own peril. TIA
Recent NWBO News
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- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 04/16/2026 09:25:30 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 10/31/2025 04:29:10 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2025 08:40:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/24/2025 04:28:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/14/2025 06:22:26 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2025 09:00:38 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/01/2025 09:04:38 PM
