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Anyone think the biomarkers are part of a FDA discussion with NWBO and possibly AA? Could the FDA be considering granting an early approval for L in it's use with those patients that "are more likely to respond to these therapies" - and would that appeal to NWBO - or would they want to go for full approval instead? -- Sentiment Stocks
We also have programs that speed the approval of drugs. Our stance is the best access to the drug is to get that drug on the market as soon as possible. Richard Pazdur, Current FDA Cancer Therapy "Czar."
Interesting video from Pazdur (FDA head of oncology drugs) at ASCO. NW will eventually need to be approved by this guy, so worth watching. Nice to see he seems to be supportive of immunotherapy. LongUSA
Very interesting. I could give bullet points, but I'll simply say he said all the right things.
OK, I had time to edit this post. I now understand you did not take my post the wrong way.
I agree that NWBO needs to ramp up their transparency, I simply am not certain the process allows much more than they gave us at this critical time. It's difficult to discern.
"Sizing up a slow assault on cancer."
This one is for you Ou. It is from the prestigious Journal, Nature.
'Rise of immunotherapies spurs search for markers of response.'
T cells (purple) can signal a slow death for cancer cells (red).
Jedd Wolchok braced himself as he walked into the examination room to deliver bad news to his patient. Scans showed that the man’s advanced melanoma had spread, and new tumours had sprouted, even though he had received an experimental therapy called ipilimumab (Yervoy) to rally his immune system against the disease. “In my mind I was rehearsing the standard speech,” says Wolchok, an oncologist at the Memorial Sloan-Kettering Cancer Center in New York. “‘I’m sorry Mr So-and-so, but the treatment doesn’t seem to be working.’” Instead, the patient stopped Wolchok at the door. “Now before you show me your pictures, let me tell you: I feel better,” he said.
Wolchok took a gamble, and continued the therapy. More than six years later, his patient is thriving, and the drug, made by Bristol-Myers Squibb of New York, has been approved by the US Food and Drug Administration. In that time, other experimental immunotherapies have shown promise, and clinicians have become increasingly familiar with delayed responses such as the one Wolchok’s patient experienced — which reflect a gradual attack by the immune system, in contrast to the rapid onslaught of toxic chemotherapies. They still have no tools to quickly discern which patients are benefiting from treatment, but that may be about to change….
Nature
Can anyone remember if we already talked about this aspect regarding Provenge?
That is, Provenge is administered in 3 separate infusions equally spaced over the course of a month; however, chemotherapy follows said treatment.
It appears they placed the cart in front of the horse. Thoughts?
I actually think you have the ability/energy to conduct a review on all 1000 or more treatment regimens conducted on various indications with this technology.
You were appropriately more conservative in this article -- which is highly appropriate for the forum; even though S.A. lets lesser works in.
I did not perceive this as a sales article. If this was the first article I ever read on NWBO and Dendritic technology, it would simply inspire me to dig into it further.
While I could quibble with a few conservative predictions here and there, it is not worth it because you really don't exclude the possibility of earlier and greater success.
Well Done.
Meanwhile, the United States allows off-label use. Right to try initiatives are sweeping the nation for terminally ill patients.
The United States allows off-label use. This will be/is strengthened for cancer patients by the addition of State-by-State right to try initiatives for terminal cancer patients.
I do not think the exposure "backfired." In the end, ASCO is about educating practitioners on a potential breakthrough therapy. If the education instead started after approval, NWBO would be behind the curve. As with manufacturing, distribution and other infrastructure, LP is constantly trying to stay ahead of the curve -- this includes clinician awareness. Education also comes in the form of clinic training prior to opening. It remains my opinion that NWBO was amazingly efficient in this process from 2011 - 2013, and the current delay in European clinic openings has to do with price negotiations and whether the 1st interim results produce accelerated approval.
Provenge at 90,000 per injection is comparable?
IMUC in a phase 2 trial -- w/o 33 patients supplying very mature data -- is comparable?
Thanks!!!
So let me get this straight LTT. Your prediction is that DCVAX-L will be approved, but you predict you know what's going to come out in the currently unknown data, and you are so clued into what is going to come out, you foresee that it will be good enough for approval but not quite a blockbuster. And….hmmm…let's see here, you partly based non-blockbuster potential upon Provenge knowing full well Dendreon's drug is so expensive that it cannot compare to DCVAX-L in any commercial respect; Moreover, despite your prediction for successful approval, your "ability" to make micro predictions informs you that bad news is "just around the corner" for DCVAX-L.
Do I have that Right?
I think nwbo eventually
gets some type of approval -- LTT
Has the poster been released online?
But….If Pyrr is right, then that concern will be water under the bridge if Celldex and IMUC have to conduct blinded trials against the new (hopefully) S.O.C.. Surgery + Radiation + Temador + DCVAX-L.
Either way, it may (partially) demonstrate the extreme bullying tactics utilized by AF are, in reality, some last ditch effort to make LP slip up -- thus explaining her proactive silence of late.
This thread started at #12039.
But then look what LTT wants LP to disclose prematurely….
Oh, one last thing...
How about a conference call to discuss Phase III results?
Huh? So, Ms. Powers, how long, how many, how good or bad?
I see...you know absolutely nothing...pleading the fifth
before you are summoned, I guess. --LTT
This early resignation by a familiar short might also provide an insight.
I think nwbo eventually
gets some type of approval -- LTT
That is a really important point Pyrr, and it could partially explain the peculiar behavior of various parties. Feuerstein pulling for Celldex, thus wanting NWBO to release their data early in order that NWBO won't pad their results, NWBO wanting to get very significant data, thus possibly moving things internally to the FDA for AA preview followed by AA application and clinical endpoint maturation….etc. (Thus sidestepping an early halt, via AA FDA process, to give them better chances for approval and to retain/maintain SOC status after they initially obtain it.)
The thesis is fine in the good, artificial light of his summary. But in the natural daylight of what the man has been doing daily for years, the thesis just makes all those actions uglier. I'm not being dramatic. That is my best description. Honest description. -- Dok
Agreed.
Best wishes to you as well Staccani.
I'll sign off until Sunday.
Have a great weaken everyone.
I agree with that.
One exception, I can foresee Direct being approved in the 15 - 30 month window. Those inoperable patients need help, and the FDA wants to help them. I think the speed could even surprise me.
Ou said:
It's going to take years and millions of dollars to get Direct approved. People here weren't predicting that before the PR. Some people here were expecting 80%-100% cures from Direct as was seen in the preclinical. Those that thought that were way off. --Ou
So without going through timelines, let's go through possible catalysts.
1. German Price Reimbursement Announcement.
2. 30 European Clinics open.
3. DMC announcement.
4. Announcement regarding AA development.
5. Further data on Direct not readily expected.
6. Announcement regarding 2 new DCVAX-L advanced products.
7. Announcement regarding revenue expectations for next quarter.
8. Announcement regarding Great Britain Hospital Exemption - like program.
9. Announcement regarding Direct 2b trial for multiple tumor injections at each vaccination.
10. Announcement regarding new FDA -- NWBO agreement.
I just "Tweeted" my very first Tweet (which I swore I would never do previously) to Fergus Walsh that he should follow up on his December 2013 BBC story on Robert Demeger in light of the current good news released on DCVAX Direct. I also reminded him of the ASCO conference. -- rrflyboy
Good points.
I remember that post.
His rule / data mine was recently turned on its head as I had previously posted.
The stat still held firm that companies with a market cap under 300 million had zero chance of success.
Market cap between 300 - 1B old stat said 18% success rate and is now at 55% success rate.
Market cap greater than 1B - Old stat was 78% success and now 54%.
So it looks like, statistically that is, we are in the best spot market cap wise to gain approval. Austin
I'd buy that….for a dollar.
Pretty convincing data mining. There have been exceptions (so you are right "rule" has been a misnomer), but I would argue that market cap, even (as one example) in allowing a company to have the resources to present a comprehensive professional application, affects approval rates.
Hmmm. Are you certain they are not one and the same with that rule?
Suit yourself. Each time he reduces S.P., he also reduces market cap, which also means less investors have to share the burden of future dilution, which means the outstanding shares greatly affect the value of your investment, which means at 10 billion market cap your investment will only be worth what it would have been worth at 5 billion market cap (as an example). Moreover, if he is successful at knocking NWBO down to a 299 million market cap into the FDA final decision, NWBO would have 0 statistical chance of approval….according to the one rule I give him ample credit for discovering.
I understand your point, but I take a different position. Can you imagine the opportunity to cross-examine a defendant who troll's comment boards, like AF, is confronted with level headed information that clearly disproves his point, and yet he continues to maintain these falsehoods in his international articles? (The screaming posts against AF would not be used as evidence, and Adam could quickly wave them away as unstable ravings. Adam wants you to scream.) The level headed, well substantiated post dialog w/adam, on the other hand, may be used to show Adam knew he did not believe what he was writing. LS nailed him a few times already.
Therefore, we conclude that counteracting the immunosuppressive glioma tumor environment via depletion of regulatory T cells is a prerequisite for successful eradication of gliomas after targeting multiple tumor antigens by using tumor lysate-pulsed DCs as a vaccine in a more stringent setting. © 2007 Wiley-Liss, Inc.
I think Smith and others should continue this tact with AF.
Educate AF. Respond to his misstatements with an overdose of accurate and elucidating corrections. Be sincere, do not overstate, caution him to get better informed and ask him to restate his false statements if he doubts the veracity regarding what he writes about NWBO. The more he knows, the less he can hide behind a veil of ignorance as a defense.
I would think ABC, who owes the world to Peter Jennings, would be interested in Direct's impact on lung cancer.** NWBO should continue to give case studies leading up to and following their presentation at ASCO -- IMHO.
The specific case study announced today involves a sarcoma patient with a large tumor mass and multiple inoperable metastatic tumors in the lung. This patient received the first 3 DCVax-Direct injections through the course of a month, starting in February. He received a fourth injection in early April and then was scanned for results in early May. At that time, this patient’s MRI scan showed extensive necrosis and partial collapse of the injected large tumor mass, and a CT scan showed some early indication of shrinkage of one of the non-injected metastasized tumors. These results suggest both local and systemic effects of the DCVax-Direct treatment, as were seen in the pre-clinical studies. -- NWBIO
ABC News Anchor Peter Jennings died today at his home in New York City. He was 67. On April 5, Jennings announced he had been diagnosed with lung cancer. August 7, 2005
Excellent.
Highly recommend.
Message: #11830
My recollection (which is not perfect) is that AVII thought this part of the guidance would be modified. It appears it was not changed from the draft. Very timely Pyrr.