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For my part, I’ve never thought the Col’s theory had merit. It never was indicated that patients would be sorted in such a manner in any of the leaked protocols, either.
Doc, the only part I differ with from your post is the section called out below. IMO, I don’t think any “treatment” induced psPD in the SOC patients caused them to cross over to receive DCVax-L. Instead, I think the SOC patients truly evented (remember, they’d been screened for chemo/rad induced psPD), crossed over and received DCVax-L, and “lived longer” (LL’s words). And instead, the treatment arm pseudoprogressed very quickly on DCVax-L, and, using the crappy old criteria, were determined to have truly progressed (which they hadn’t, but this ruined any chance of PFS being used in any request for accelerated approval).
I often lament that the criteria wasn’t upgraded in 2012 when they changed the trial from a P2 to a P3. Cie la vie.
Hope no one has their GBM spread to their spine as a result… like what happened before using CAR-T at Hope to treat GBM for a doctor (who died).
Should the MTD not be granted, it’s possible there may be a few of the MMs who would rather pay a largish sum of money than move forward to discovery. Large sums of money from any settlements could help to fund ramp ups, other trials, marketing, without continued dilutions, IMO.
I wish we were at discovery now, but the magistrate did telegraph what he wanted added into the complaint back at that meeting in mid-November… so we should be seeing that added in by mid-March by Ms. Posner. Then the usual back and forth, and then a new ruling… hopefully in Northwest’s favor. :)
I agree with your explanation.
After seeing what’s happened in the DCVax-L GBM trial, I honestly don’t see how one can do a truly randomized trial of DCVax and include a crossover. To me, it’s obvious DCVax works… you typically don’t get recurrent GBM patients living as long as they did/do in the DCVax -L trial, and as the control patients in what had been a randomized trial, these were the patients that received the drug upon real progression, IMO.
This case is starting to get some legs, IMO, with some interested eyes on it. If it survives the MTD, we should see the number of interested, influential eyes vastly increasing.
And mine has the MAA submission stickied.
Always love your uplifting, detailed posts, Chiugray. :)
Thank you for your response. I hope that you enjoy your holiday.
I just wanted to quickly make a response to your answer to me.
First… let me state that while I’m sorry that you’ve gone through what you have, please consider how lucky you are that your diagnosis was either incorrect (you never had GBM or an Astrocytoma) or you did, and it’s gone. As an aside, one could wonder if the infection killed off an Astrocytoma that had begun, which, if that was the case (and this is only a hypothetical and probably unlikely) that would make you extremely lucky to have had that infection in the first place.
I do, by the way, believe you live in the UK and that this your perspective as to what happened in your case.
Second… with regards to your comment,
I'm glad to read that you're doing so well... IMO, you're lucky and there are many other GBM patients that would love to be in your shoes.
What I don't understand, or perhaps this is not what you are meaning, is why your experience, which did not involve DCVax-L, would be pertinent to the upcoming CHM meeting re: DCVax-L. Could you give us any detail on that? Or is the CHM just interested in hearing from GBM patients that have lived past 5 years?
Absolutely not referencing you, but rather the one looking to “debate”, just for the pure fun of it, lol.
Note: as flipper points out, I did NOT mean that last response (as stated below) to be directed at the good Captain O.
No worries… I guess if you have nothing else to do with your life but to seek out “debate” about a stock you’re not invested in, have at it. But at least stick to discussing the stock, since presumably, that’s what you’re here for.
Captain's response to you was that Ferrari makes tractors.
Perhaps consider moving on to some new line of attack as this one is not only wrong, it's getting stale.
Such a vaccine would still be partially personalized as the dendritic cells themselves would have been developed using Patient A’s own leukapheresis material… interesting thought, on your part, IMO. :)
And sometimes they’re mods, and probably shouldn’t use the ignore button. :)
Thanks biosectinvestor… great, very detailed response to our board’s latest fudster… wasted words, I’m sure, on him, or her, or him posing as a her, but not on our longs. :)
OMG… not the Swiss thing yet again!
Rather than write it all over again, anyone interested in reading about what the other side of this discussion might be can go back and read my posts on this topic. And if you click on my links in each post, it’ll take you further into the details.
The Swiss approval is a topic ex lives to bring up every six months or so. It’s so boring, really, but it’s simply not at all as ex et. al. presents … and delving into the details is really the only way of proving it. So if you’re interested, follow this thread.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=142399044&txt2find=Swiss
It’s pretty easy to tell who are the paid badgers, tho. They, too, don’t have clue.
This quote from her also popped out for me, given DCVax is definitively a personalized immunotherapy and also really represents a platform treatment.
This DcVax-L trial has its own psPD arm with 32 patients that they stopped enrolling into as of May 2014 (but you know that already). So those who were Chemo/rad psPD patients for the most part enrolled that arm (which is likely now part of the Expanded Access Protocol (EAP) trial.)
Numbers do vary, and a good number of chemo/rad psPD patients present during those first three months. That’s why the trial was set up that way.
Most chemo/rad psPD patients were screened from entering the main arm of the trial. Therefore, there were likely very few, if any, psPD from chemo/rad patients in either the treatment or control arms of the trial.
Well said! :)
You love to bring up how I hadn't invested prior to investing in Northwest, and that simply isn't true.
My husband and I were heavily invested in Apple ($460 about 4 or 5 splits ago), with smaller investments in Netflix ($330), Facebook ($40) and other tech accounts that have risen considerably, and had we stayed in them instead of eventually moving more into NWBO, we would have done very well. The other biotech investment we were in was Ariad with an average of about $6 per share, which was later sold for $24 per share, but by then, I was heavily into Northwest and was no longer in Ariad. So right now, with the price where it is, we're unfortunately about even, so only time will tell if we made the right choice.
I talked about Northwest to quite a few of my friends in the past, but I didn't recommend it... I talked more about the science and the shorting that was taking place. Only a few of my friends are in the stock, and with extremely small positions. I later learned that my brother had bought a small number of shares, and then learned that my niece and sister in law had bought a decent number of shares when the more recent run up took place after the Flaskworks purchase was announced (without mentioning it to me). My daughter is in it... and yes, we encouraged her to purchase the shares, and she is so in the money with an average price in the low $0.20s. Finally, my brother in law is also in it with about 50K shares. He is also in the money with an average price also in the low $0.20s.
So that's it, so you may want to quit with this tired narrative, or at least change it up based on what I've laid out here.
Very true, Gary. :)
Thank you, Am813. That’s very helpful to know, and explains why they (the plaintiff) didn't take that route. And now they will.
Ah, ok, if you’re correct, then that somewhat explains why she (Laura) didn’t amend the complaint on this round.
But she could have done so based on the magistrate’s suggestion, prior to Wood’s ruling, right?
Still, even if she had, we’d still be facing all the response steps that would follow another amended complaint. So really, we’ve added maybe one or two months to the process, IMO.
The magistrate suggested it be given in another amended complaint in his R&R.
Interesting that that’s your interpretation of the magistrate’s opinion on the loss causation section… that he was skeptical. That was not how I read it… I saw it more as he wanted to give the plaintiff the chance to strengthen their case.
I guess confirmation bias exists on both sides.
Interesting… so the formula wasn’t included in the first amended complaint (the complaint that the judge just ruled on) and the R and R did request that the formula be given in another amended complaint. So here we are, and that’s what come next… a second amended complaint, delaying the case from moving forward past the MTD for now. But hopefully perfecting the complaint to be able to move forward.
The magistrate didn’t ask for evidence, he asked for the formula used to calculate plaintiff’s losses.
Opens up new lines of argument from the defense that perhaps the plaintiff would prefer to put off (if possible) before moving to discovery. That’s a plausible answer to your question, anyway.
The magic sauce is that they provide the formula. That’s what the magistrate asked for… and they have it. Not sure why they chose not to give it when that’s what he asked for as that’s obviously delayed this case further. But whatever the reason… (my guess is they don’t want to give it yet to the defendants, who will present new arguments to try and refute it, and ultimately, it will require experts anyway from both sides to weigh in)… they’d better give the formula now, because that’s what Stein asked for. They took a gamble (that the MTD would be dismissed and they could hold off on presenting the requested formula, lost, thus delaying the process further. That’s all, IMO.
Navid brought in Woodford’s investment money… I think that was around $180 million?
Interesting thread.
I’m still wondering about Car-T and the killing off of the B cells. If the B cells eventually regenerate, couldn’t that, too, trigger the leukemia the Car-T had treated to return?
Are you thinking of how they inject both arms with L?
That’s ok… we’ll get there eventually. It was still a great post with great detailed information. I’ve also over estimated on occasion as well (remember I’d thought patients wouldn’t have to go to England for their leukaphereses?).
Thanks ex.