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That information is both reassuring and pathetic at the same time, but unsurprising. So, I agree. It could be someone(s) at UCLA slacking off. I did ask Les directly, on two separate occasions, whether the commencement of the Opdivo combo trial was in any way, shape or form contingent on the progress or results of the DCVax-L trial and both times he firmly stated "No".
Abeta: Check out the link posted earlier today to Larry Smith's response to that to get a little bit of a back story.
Flipper: I'm responding from my phone, so I'll be briefer than usual for now. Yes, I remember Cobb's comment and was a bit thrown by it then just as I am now reading it again. My reply is, I don't know how to reconcile that with what seems to be prevailing observations in IO.
Regarding inflammation within the skull, I would just suggest that such inflammation on a recurrent tumor would likely cause a smaller mass than the original excised tumor.
But, as is generally the case, I'm theorizing and not attached to my theory whatsoever.
Flipper: I don't KNOW (wish I did, because I understand why it's extremely relevant viz. halt and more), but I'll tell you this. And this, unfortunately, is only based on my recollection because iI didn't take notes back then: Shortly after TFF became a topic of discussion (and I am thinking that was after the halt), I asked Les something to the effect of whether the Germans saw this as the best method at that time, and if, because of that, the company would switch to TFF treatments in Germany. Again, this is a hazy paraphrase, but I'll give you the take-away. He said something very much like, if not verbatim, that it would be like shooting themselves in the foot to change protocol mid-trial. Does this mean that, in fact, they didn't shift to TFF? We know the answer is, Of course not. But that's what I recall being said.
N.B.: I can't even remember my iHub password without Dashlane, so take this for what it is, a recollection.
I think that a substantial collection of quotes from experts and people on the front lines would make a nice sticky. I'll gather a few more, too.
Thanks, Senti. Here's a very brief synopsis of actual statements by people who are in a better position to judge than Joe-anonymous on iHub (and they are all paraphrases since I'm not about to waste time getting original material in order to address this):
LL: They're all living longer..
LL: DCVax is my proudest accomplishment.
Dr. Cobb: The results of that trial seem promising.
Dr. Ashkan: EU Lead investigator: "DCVax is important because because I genuinely believe that immunotherapy is the way forward for brain tumors because I think there's nothing cleverer than our own immune system to be able to cope with variations there […] brain tumors are difficult is because they are very heterogeneous, extremely genius, no tumor is the same in two different people even different areas in the same tumor are not the same, okay, and the only technology we have which can cope with that amount of variation is your own immune system. Why? because over ten million years it evolved to protect you against millions of pathogens, right […] what should we do? We should prime our own immune system to attack the tumor hence the individualized therapy called DCVAX. The reason I’m keen on that because I was the European chief investigator for this trial which we finished about I think three four months ago now we are waiting on follow up data."
And, there are several more.
Also, as you very ably explained, it's not the norm for NICE to even consider a treatment that has yet to be approved. And, among those few that they have considered pre-approval, they have ALL gone on to be approved, most within a few months of NICE appraisal.
I think I heard Dr. Pearlman say about DCVax, "And it has shown a tripling of overall survival." Is that what you hear?
Tripling of OS. Now, chew on this from yesterday's FiercePharma reporting on results of a Opdivo-Yervoy trial and note the analyst's response:
Thank you. I assume that the Dr. saw something he liked.
I have a pretty good theory, but I'd have to MOD myself immediately if I shared it. That post is like a very bad version of Groundhog Day.
A chemist who worked for a ghost company. Hmm. What's wrong with this picture?
eagle8 - I'm so sorry to hear of the loss of your sister. I've lost a sister too, way, way too soon.
For all the dramas and debates here on the board, I know that there are members on both sides of the 'aisle' who feel your loss and are here for you.
I truly hope that DCVax can help cancer patients go on and live their lives.
Oh, how quickly we forget! The Wolf/Ondra episode is a book unto itself. People are quick to pick on LP's actions while turning a blind eye to the underhanded activity directed toward the company. In the meantime, there are sick people who need help and hope.
Thanks, Jack It's great to read about Jamil Newirth's perseverance and recovery. Apparently, his data is not blinded:
Yes, that's the reality of it. People who expect fireworks to be set of upon the unfortunate 233rd event aren't seeing the broader picture. I asked Les about three weeks back whether, after 233, the 'data scrub' would be the entire data base or only the most recent events, and his answer was 'a combination'. I take that to mean that it won't be a case of just plugging two more events into the equation but, rather, a review of the entire data before anything. Everything is riding on the data (duh), so there is good reason not to go forward half-cocked.
I have faith NWBO know what they are doing.
Volume dropped precipitously yesterday and today. At the moment, NWBO is at about 26% of its 65 day average of 2.1m. Did August 1 change things? No way of telling. However, I must say that I found your post extremely intriguing.
If you Googled for your page, then open Google again and check the upper-right corner of your screen for what look like overlapping rectangles and click that. You should get all the past pages as they were when you saw them. GL
Franky: not sure it would be useful, but why not try looking back in your browsing history to see whether the page you saw earlier is cached?
Sox: I think it's a good idea to make people aware of this. For better or worse, I think a lot of people consider that a perusal of a message board is equivalent to doing DD. And, I agree. They see the shorting report and do think there's trouble ahead. It all means squat to those of us longs who are in for the long haul, but your elucidation is a service to new eyes.
Cheers
"How is a strong-minded person who knows that what he sees is by its very nature nothing, consider one thing to be grasped and another to be rejected?" Astavakra Samhita.
Shanti.
Another famous Sanskrit invocation goes something like this: 'May our eyes see the good; may our ears hear the good. May Peace be everywhere.'
For me, that seems like good advice. So when I see someone reaching out to help another by informing a doctor of unfamiliar options, I personally see it as that person trying to do good. Just another point of view.
Thank you, Senti. You've been busy!!
Semantics?
Excellent article, KarinCA! Thanks for your efforts.
I agree totally. Think globally, not locally. Dr Chan telegraphed the value of Cytosorb as an adjunct treatment to CAR T. Downside of CAR T + Cytokine storm. Cytosorb can prevent cytokine storm. Perfect match.
To add to what you suggested: Consider how much all of the short and FUD activity adds to the cost of bringing a trial to completion and treatment to market. If Congress is serious about reducing the cost of treatment for the consumer, they should start by reducing the cost of development by: a) banning short sales in biomed/pharma, and b) getting FDA to make trials and approvals time-effective. And, particularly in cases of fatal diseases like GBM, the placebo arm should be a thing of the dark past. Simulations and historical data should suffice as comparators.
Thanks, Branko, for this work. Would you mind expanding on this?
Thanks Flipper. Somehow, I think they're hiring at this pace for something bigger than rounding out the Cognate softball team,The DC Vax.
Yeah. I can't and won't try to speak for Dr. Bosch ('cause I can't do the accent), but that's an awful lot o' shares at .25. An expensive head fake, if it is one.
Thanks Survivor1x. You've made the point extremely clear, IMO.
And I hope 1x is all that's necessary for you. All the best.
I gotta believe that their eyes are on getting DC Vax L over the goal line, meaning they have to put everything they have into ensuring that happens. I think Direct will get started in earnest once L no longer needs a lot of cash to move forward. They're already spread really thin. When will this be? I wish I knew.
That's it. Nicely done.
OK, so I admit I feel a lot like Wylie Coyote after the anvil falls on his head, again. The CUSIP change hasn't yet meant a thing that we can see. But, like Wylie, I'll keep on keeping on.
Yes, that's right. Only the naked. I'd bet that those numbers will be in the tens of million shares.
Absolutely correct. Shares must be accounted for. Nakeds better throw a towel on.
Shorts are toast! All shares must be accounted for!
learning: That disclaimer is required by ASCO. FYI.