And just to further educate you, Cognate keeps the vaccine until needed (take a look at how it's dosed, per the trial protocol, so if a vaccine isn't used and is still in the cooler when it's supposed to be administered, what do you think happened to the patient?). Also those in the placebo arm won't get the real stuff until they progress, but the vaccine was MFG when they were enrolled.
I may be completely uninformed as you state, but at least I can figure out a very simple process instead of actually believing Power's or anyone else outside of the DMC knows enrollment numbers or can figure out survival benefit. Why do you think Power's won't release the numbers?
Is this how you always invest in companies?
"Powers doesn't know anything about efficacy OR Enrollment numbers"
Really? I guess Cognate (who Linda owns controlling interest in just incase you didn't know) who makes -L for this trial is just randomly producing vaccines and has no idea how many or when they made them.
Oh, don't forget the crossover arm of those receiving placebo, so anyone enrolled is having -L made.
So it must be very difficult to keep track of that.
You are right, it would be impossible to figure out enrollment (much less survival) numbers in this trial.
You are right again, it would be extremely difficult to determine survival benefit on a double blind trial when the company knows enrollment numbers and when they were enrolled regardless if they were given placebo or not considering they are using Stupps data for avg survival. It would be impossible to figure out survival benefit of those in the trial.
There is no way anyone can figure that one out right Buzz?
Power's was just bored, she also enjoys begging for cash so she decided to not only increase "events" (more than double) for the next review, but also lowered the threshold to show benefit. Doing this adds about a year to the trial.
I doubt it's due to technicals, it's more that they will need quite a few more cash raises and are a ways out from any type of approval.
They need to secure enough cash for a run-way to regulatory approval of either L or Direct before a significant swing in stock price will stick. Until then, the volatility will continue.
You might have a point. I wasn't a fan of Power's increasing the number of "events" which happened right after the last DMC review. My only guess is the DMC did do an efficacy review (which Power's didn't make public) and it was inconclusive, so Power's increased the events of -L to keep the trial going long enough to give time for Direct to gain traction to keep the stock from going back to penny land while the Direct trial continues and hopefully continues to show stellar results.
I also believe that the only hope for -L to approved without an additional phase 3 is a halt on efficacy. If the trial goes "full term", I think the FDA will pick apart the trial and request another which NWBO will have to do with sub-groups (which will also narrow the treatable population).
Just my thoughts, I could be way off but this is the only scenario I can come up with.
NWBO, lightning in a bottle or a firefly in jar, only time will tell.
That's pretty rich... PD1 and ampligen, why would this work? Nothing else has panned out.
Ampligen and CFS = dud
Ampligen and Cigarettes = #$%$ was Carter thinking
Ampligen and Ebola = dud
Ampligen and flumist = dud
Ampligen and Bird Flu = dud
Ampligen and SARS = dud
I'm sure I missed few indications that Ampligen has been promoted over. Too bad not one thing has panned out.
And as far as being "ready", take a drive by the defunct MFG plant that has been "under improvements" for the last 8 years that is continuously 18 months out.
For one you are assuming -L works, no knows this yet. Well how happy would you be if you were in the trial and it was stopped for futility only to find out the company was just playing money games with your life? Power's increasing events and decreasing benefit at the same time isn't exactly a vote of confidence in -L.
I haven't been able to find one nor has anyone else.
The FDA's job is to determine if it's "safe and effective" however, I think the FDA is as corrupt as wall street if not more.. take,Lyrica for example. But if a trial is halted by the DMC, the FDA has little to no room to pick apart the trial design to get their "tribute aka bribe" before approval.
That is why IF -L receives a recommendation of a halt by the DMC and Power's ignores that and continues the trial to the end, not only is that unethical to those in the trial (crossover arm has to progress first before receiving -L, if the trial is halted, they will get -L BEFORE they progress) but it gives the FDA ways to scrutinize the drug/data etc.
"I have asked on both boards for examples where a PH3 Drug has been stopped for EFFICACY
by the DMC and then the FDA has NOT accepted the recommendation and made the PH3 trial be effectively restarted ?"
Thanks for being the voice of reason Steven. If the DMC recommends a halt for Efficacy in a phase 3 trial, there is not ONE instance where the FDA has requested an additional trial BEFORE approval.
A phase 3 trial halt for efficacy (as well as being safe) and for a condition such as GBM or any other life threatening disease, particularly one that has no current effective treatment, a trial halt for efficacy is the Golden Ticket to approval and there is NO WAY the FDA would ever request another trial before an approval. It has never happened, it never will.
I understand there is a crossover during the trial, however, they have to have disease progression to be transferred over.
How ethical is that if the trial was in fact able to be halted but the company choice to continue.
How would you feel if you were given the placebo, then had disease progression then given -L only to learn you could have received -L much earlier but the company didn't want to halt the trial. It's just your life right? No big deal.
"The EF-14 trial Independent Data Monitoring Committee recommended terminating the trial early and allowing all control patients to receive Tumor Treating Fields"
"Based on the interim analysis results, the Independent Monitoring Committee (IDMC) for the EF-14 trial recommended that the trial be stopped early and that Novocure provide access to TTFields for patients on the temozolomide alone arm."
With just a 3 month survival benefit.
So when Power's said "They prefer to finish out the trial being that its so close to completion and that ensures the regulators will be on board. Otherwise FDA might not agree and since it would have to be unblinded they would have to start over if the FDA did not accept the halt."
So instead of Halting the trail and giving EVERYONE started in the trial DCVAX-L, Power's would prefer possibly killing those getting the placebo because the FDA may not agree with the results and to do a new trial. So basically she is saying she would rather kill people than halt the trial for efficacy.
Complete BS in my opinion on Power's stating that. It's ethically wrong provided -L is showing a benefit.
If Power's would release enrollment numbers, a more accurate model of L could be summarized. My guess is -L is not showing efficacy and she is holding that one off while Direct gains traction so the stock doesn't go back to penny land.
I hope I am wrong about -L and it is showing a positive effect.
While I think Power's has done an amazing job with NWBO considering she has little to no Pharma background, I am amazed at some the words that come out of that woman's mouth.
I'm with you! 2015 will be the year for HEB! I see a reverse stock split followed by a massive at the market share sale to raise cash for a nice bonus and perhaps anther vacation home for Carter!
Shareholders will have nice depreciation in share price along with sizeable tax write down from their "investment" in HEB. THANK YOU CARTER!!!
" I say twice as big as Pfizer and Astra Zenteca combined. That's how big Alferon and Ampligen is. Big pharma is shaking in there boots."
Is it already April fools or are you a complete idiot? Carter hasn't even met with the FDA from the last CRL 2 years ago but he has paid himself over 2 million bucks since then. I'm sure a million dollar bonus is right around the corner.
"Its that time for another juicy bonus, A new car, and some great vacations And while your at it you should pass out some nice raise's to you managers and board members"
Merry Christmas to all HEB bagholders... I mean shareholders! William Carter
Considering the hodge podge of SEC filings showing ownership, it's extremely difficult to make sense of it all.
Power's could be playing games is my guess.
The good news from this is now that it's documented, Cognate and Toucan will have to disclose sales since they are over 10% owners.
Lets hope it keeps climbing! I've got some 8 buck options coming due in Jan!
Right buzz, you know it all.
Find me ONE phase 3 trial that the DMC halted for efficacy that the FDA did not approve and required an additional trial PRIOR to resubmission for approval, find just 1 and I will shut up.
Buzz does not know what he is talking about and apparently neither does Powers. .
IF the DMC halts a PHASE 3 trial for efficacy, that is the Golden Ticket to approval. If Powers wants to continue the trial after a DMC phase 3 halt, Power's should not be CEO.
The FDA may request an additional trial, but it would be confirmatory, rather small and happen AFTER approval as not to keep a safe and effective drug from those who need it.