to help out his short hedge buddies from getting creamed on the German FDA news.
and it worked.
the sp won't likely go higher now until or unless more positive results come in.
sheesh, that guy is a dork but he works good for the shorts.
what drove the German FDA to decide in favor of approving use outside the trial?
maybe the DMC reviewed the European data and it merited approval based on efficacy in Europe.
But the US data may be on the verge but not there yet.
so they say efficacy data is pending and monitor more cases.
so the US data may not be far behind Germany or they may just wait to power up the results.
It would be rare that an initial look results in an efficacy call but then again, GBM is unfortunately a fast acting cancer.
and Europe is waiting on the US data to firm up with the DMC to crossover all patients together at same time in the US and Europe.
all conjecture, but seems possible.
that other poster has a good point. the web site says that the trial is being run both in the US and Europe. Maybe Germany has their own version of a DMC working the European side or there is one DMC but they closely reviewed the European data and coordinated it all with Gerrmany's FDA. why? maybe the stuff actually is doing amazing things in numbers.
There are soooo many naysays out there, but it seems logical, that maybe Germany's FDA was coordinated and shown some amazing results. something had to tip them over to the side of making it available. something,..
How could that be that they had access to see the P3 data? I doubt it. when they say all I think they meant all available data which does not include P3 data. If the Germans got the data and decided on basis of P3 then what is the DMC waiting on? if they decided on P3 data that seems like it would have to be considered as a leak of the data that the DMC is working.
first, in my observations of human nature, it is obvious that adam feels supremely confident to the point of arrogance that DC VAX L will fail, like others in the antigen puree approach and directed antigen as well like IMUC failed, So he doesn't care how he looks (even if he looks like a JERK) in trying to bring down any and all enthusiasm to the early reports of success because he doesn't believe it. He is not alone. There is a wide body of short sellers and put sellers that do not believe and secretly if not blatantly deride all of the bullish sentiment towards NWBO.
On the other side is results that show GBM patients on DC VAX L living 3 years after diagnosis, some longer. Ted Kennedy treated his GBM aggressively with surgery, Chemo, radiation and probably the best care possible and lived 15 months. Apparently, The German version of our FDA reviewed the known information on DC VAX L and approved the use of DC VAX L outside of the trial. This would seem to be a strong endorsement of DC VAX L.
The German approval for compassionate use and yet be negotiated reimbursement to NWBO was the tipping point for me that said get back in. BUT , this is huge BUT - it remains to be proven. The skeptical side of me says the amazing rarely happens in these issues and that's why the shorts are so confident. Also, they do not believe the immune response will be strong in large numbers. . On the other hand, what if people like Ted Kennedy had DC Vax L ? maybe that 15 months would have been extended into 3 years or longer.
The key question to be answered is the puree response going to be strong enough in enough people to meet the Phase 3 bar of statistical significance? IMUC was a targeted antigen approach and failed.
The bulls saying put the farm on this are offbase in my view. But some to see if the amazing will happen and NWBO will beat the odds and succeed is an interesting proposition. The jury is still out and only the data will speak.
I am long. I took a sip of the Koolaide.
But until the phase 3 DC VAX L proves the case of efficacy in large numbers, it still needs to be proven.
Oh well, back to square 1.
waiting on the DMC .
the F-Stein bash article was a diversion to create FUD for shorts.
But it still needs proving.
I'm in because the German FDA gave DC VAX L a strong endorsement in my view.
now we'll likely have to wait a year to see the p3 results.
but Adam lost all and any credibility in his recent attempts to orchestrate FUD.
NWBO refute the main claim that they waited on the PR to manipulate the sp.
THAT was perfectly appropriate.
Other than saying the trial is on track is all they can say.
The trial is on and the DMC is active in reviewing the data on going.
that's all they know so asking for more and then deriding them in a pompous arrogant way just shows F-steins true colors as a short bashing idiot trying to create FUD for his short hedge funds that got skewered on the German approval.
no doubt adam is representing short hedge funds who have made a lot of $ shorting small cap bio's with a p3 compound. His practice is do that, bash appropriately, and rake in the money when they fail. Most do, that's why he does it.
The only thing to do by a responsible co is to not ignore him anymore but if he misrepresents the truth, then a refute is called for because he does a LOT of damage to small biotech. When they fail, he say's see I told ya so and when they succeed he says oops.
In the meantime he's gambling that dcvax l will fail so he can lsmugly say I told ya so.
But NWBO s refute was perfectly logical and they were required to get approval on the PR from the German authority. So Adam coming out with half baked replies and deriding NWBO for not having the results from the DMC is just short bashing FUD.
cause that's what they do. Cramer and team. Then Cramer goes on TV and acts like he's for the little guy.
excellent rebuttal of Adam's bash article. He misrepresented the truth. Now we see his short sided motives revealed.
Adam will set up straw man failure scenarios for any small biotech with a Phase 3 compound. Then he will state his "opinions" as fact and continuously post negatively spun articles as his short hedge fund pals keep shorting, knowing they have adam in their back pocket. Since many small bios do fail, they feel the odds are with them. However, it's the spin they use to try to manipulate and defend their position.
What we saw yesterdays in Adam's 3rd negative spin article was the result od scared short sellers desperately trying to salvage their positions.
But the German FDA endorsed DC VAX L based on their known available data. That is a fact not spin.
The Germans are very rigorous and surely must have reason to approve reimbursement to NWBO and a desire to make treatment available beyond the Phase 3 trial.
Adam's off base on this one and motives are transparent.
The data on the Phase 3 are only known by the DMC. Adam tries to spin everything negative to protect his shorts. The one thing that can be done is for the Company to prove him wrong by either statements or performance.
sometimes we just have to wait and see.
while it was not the phase 3 DMC data, it must have been all of the available data they have.
Now if the GERMAN FDA decided to make DC VAX L available outside of the GBM trial and also allow NWBO to be reimbursed. then there the logical conclusion is that the EXPERTS in German FDA believe there is strong evidence of efficacy.
It goes beyond an unmet need.
They reviewed the available info to date and how many times does that happen that the German FDA experts agree to do that???
it must be working.
first, the main reason to wait on the efficacy part of the DMC is likely because the trial is on the verge of a stop on either futility OR efficacy and as they monitor the on going trial could announce the result anytime or wait until the next look.
what tips the scales to the side of efficacy?
The Germans reviewed the available data which is not the phase 3 trial data but likely includes an extensive review and decided that it must be effective enough to PAY for it the the hospita; exemption ruling.
Now what of the Placebo patients in the trial?
This is not exactly fair that people can get it but placebo soldiers do not .
as far as if they waited on the PR about German fda approval for use?
think about it.
the pressure was on for the DMC to report findings. NWBO did not and does not know the results.
I think they chose not to cloud the impact or importance of whatever the DMC was going to report with ANY other news until the DMC findings came out.
DC Vax L is on the verge of a stop in my opinion.
The German FDA decision means they want it there first.
There is a Company in Germany called Merck KGaA who is likely watching very closely because a successful DC Vax has big implications in treating a broader market in all cancers and our FDA knows that as well.
This co is alike a powder keg that could blow higher anytime.
a stop on efficacy or a takeover attempt anytime.
Until the DMC announces there's always some risk but there are strong indicators with the German FDA that the stuff is working. The Germans are no chumps.
this stock has the potential to see $30 on its own within a short while.
It really could see $100 because the treatment would be ubiquitous across cancers.
1, the German FDA has seen enough to know DC vax L works .
2, the Germans want manufacturing in Germany.
3. Next step..
watch for a hostile takeover coming by Germany's Merck KGaA.
They know it works and will likely pounce sooner than later.
It's quite clear now.
without a takeout, NWBO would see $100 a share and higher.
But a takeover may see NWBO being taken out at about 30 if it does not jump there soon and then they would have to bid higher.
and If they allow all people with GBM to have access , how long can they continue the trial with Placebo soldiers?
doesn't seem fair and does that point to a stop on efficacy coming sooner than later?
seems to me it does.
this stock could go to $100 a share because GBM would just be the start.
what do the German's know to make them approve it outside the trial and PAY NWBO for its application?
last I heard from tasty he was into nwbo puts and is a serious skeptic.
I don't see how the germans would approve to pay nwbo without some serious evidence of efficacy.
perhaps the amazing is happening on nwbo. I never know for sure anymore on these issues.
anyway - took a small sip of that nwbo Koolaide and back in some.
If it does work in larger numbers it will be amazing.
WHY would the Germans review whatever data they have and then just decide to allow all GBM patients
to have access to DC VAX L and to pay NWBO for it?
and WHAT about the poor placebo soldiers in the trial? It does not seem fair to them.
Ok maybe it is time to say evidence is mounting to success and take a sip of that Koolaide?
I'm back in some.
Is "the amazing" on the verge of happening?
the verge of a stop on efficacy that is as they monitor the trial?
only time will say but what do those German's know now?