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Please show me where I ever said LP was a crook. You are confusing me with someone else. Maybe everyone voicing concerns 'look' the same to you.
"Of course B4Bluesky does not have the details either, so when he said he believes it is likely that new financing will need to take place in a matter of weeks"
My opinion is based on the most recent known quarterly cash burn. What is your opinion that they were sitting on a pile of cash, but decided to finance in the 3's just for the heck of it based on? Maybe the less complicated explanation that they needed more $ is the most logical conclusion?
"If they did use up all of NW funds, I would sure like to know what they spent it all on"
So would NW.
Unlikely. I anticipate no news. Rather, I think we see a 10k filing extension. No news on the investigation as it will not be complete (we were told a minimum of 90 days starting 1/1/16) and no explanation of the clinical hold.
You should probably buy some OTM March calls though since you are so sure. Think of all the money you'll make..
The last financier would only buy shares with warrant protection. Are you familiar with how these work? I'll give you a hint. The drop in SP after the financing tells you everything you need to know.
True. And are they currently testing for 1st line treatment? No. In fact, there's evidence that some immuno treatments show efficacy because of the synergistic effect with the other treatments. Who knows what stand alone efficacy would even look like.
They are years and many clinical trials away from even talking about stand alone SOC. Therefore, the "BP is out to destroy us" argument is completely baseless.
No. I'm just part of the collective market that feels this way. Maybe you haven't noticed the current value of the company.
Highly doubt that. If so, what's your explanation for the last distressed financing at such unfavorable terms?
Please explain how big pharma has anything to lose when NWBO's treatment is applied in combination with radiation and chemotherapy. You have said many times that they are afraid of losing billions. Always in conjunction with a conspiracy theory about how BP will stop at nothing to protect their turf. Thanks!
I would like you to specifically address the adjuvant issue. Thanks!
Well, as the end of February approaches, I am reminded of comments made at the annual shareholder meeting about how busy everything was going to be during the new year.
We haven't had a status update on anything. Wondering if those comments had similar merit to the statement that the shorts were very vulnerable, right before several million shares were sold for a couple bucks and an escape route was delivered on a silver platter. Or maybe when we were promised that Direct 2 would "start "soon" back in 2014.
Now, maybe they are sitting on a gold mine and have to keep everything close to their chest. Or maybe they are sitting on a beach someone sipping a pina colada. How would you know the difference?
Your argument makes no sense. Very low probability that this treatment is ever commercially viable.
And even if it somehow defies the odds, it is an adjuvant to big pharma's products. The theory that BP is behind an attempt to destroy this fledging company is nothing but a fantasy designed to keep the hook set in the sucker fish and the gravy train rollin for the 15th, 16th, however many years it's been now. In other words, complete HS.
"Sawston is being readied to meet demand, before Accelerated Approval is applied for."
If you're right, we are talking about years before Sawston is completely readied IMO..
At what point does excessive dilution become a concern like Smith warned about in his last article? Thinking we see the next financing in a matter of weeks. Based on the last one, what are your projected terms for the next? Thanks
Appreciate your knowledge and resources. You seem to have accumulated a wealth of information and experience through the analysis of many clinical trials. Curious if your in-depth analysis of FDA written opinions, regulations, and clinical trial guidance was a result of your pursuit of information related to your family member's illness? You say your expertise is far removed from biotech, clinical research, and investing. So what field are you in? Surely there's no risk of revealing your identity in divulging your area of expertise. I would guess engineering. Maybe even a little carpentry in a past life..
Also, thank you for the explanation/justification regarding Pyr's alias on the other board and how the purpose of the alternate identity was to facilitate honest and respectful dialogue. He has tried similar strategies on this board and on the ymb. One such alias was created under the name of Michonne. No doubt also intended to initiate intelligent conversation with us in an uncharged and respectful manner. Thank you for reminding us how pure his intentions have been over the years.
It sounds like you were perfectly positioned and prepared to deal with the "devastation" of the clinical hold last summer. Have your largest gains as an investor come from the long or short side? How about with NWBO? Someone is about to make bank in less than a year when all of those NWBO call options expire worthless. Thanks and I wish you continued prosperity.
I agree thst he is desperate and it sounds like you are generous. Hope it was something of appropriate quality like ChocoVine or Arbor Mist, and that it was properly aged in 100+ degree temps and direct sunlight for a few days beforehand.
Glad I could do that for you. Maybe drink some wine and try not to be so uptight about everything?
Lol, now that's actually quite funny. You may be a dink, but you've got a quick wit.
Dogoo said:
"There is one owner with a lot of shares who may or may not be manipulating the share price. My guess is that he wants more shares/more control. Provoking circular dialog, creating doubt, through the methods you described may be motivated to shake loose weak hands."
To which you replied:
"Don't think for one moment its not a coincidence that the "volume" has been turned up as of late."
My point was that there hasn't been any trading volume to support the theory that the "rhetoric" is being used to shake loose shares. Basically saying the main point of yours and Dogood's post was BS. Sorry I underestimated your ability to interpret my double meaning..I thought it was quite clever.
"Don't think for one moment its not a coincidence that the "volume" has been turned up as of late."
150k shares traded today. Seems a little muted to me rather than "turned up", but don't let facts get in your way..
Flipper, how much longer before the Powers that be figure out how to resolve the issues that "haven't been helping the study" and those that can "wreck havoc on clinical trials"? Weeks, months, years? Is it even salvageable? The market thinks not. What do you think?
161k volume in the $1.80's. NWBT, the hidden GEM that dreams will be made of.
Buy buy buy! Load up before blast off! Going to the moon any day now. Stay tuned.
I'll be back next week, after another week of no news, to tell you to stay tuned. In fact, I'll do it every week until the next time Linda releases a PR, when she will say it to you. :)
What kind of rec are you expecting?
I agree. Without resolution of the partial clinical hold, and a favorable outcome of the investigation, there will be no continuation of Direct. Even though the company said the last financing was for the Direct trial, I think we all know better. And the months pass by.
Beach, Senti, Flipper. How long of a wait with no explanation as to the reason for the partial clinical hold before you all will agree something major has gone awry with the L trial? 7 months, 10 months, 1 year, 2 years?
Right, the institutions don't have anyone as smart as the folks on this board. So they haven't figured out yet that they should be buying at these levels.
I think the bollinger bands suggest that we have bottomed out, I mean they are tightening, so we should blast off any minute, I mean I am thankful for each drop in price (a big thank you to AF) because I can add more. Whenever it drops, I don't even think about the impact on all the shares I purchased much higher, I just think about the chance to buy even more at a cheaper price. I love the current price!! I can buy in the $1's and I plan to hold and sell over $200 in just a few weeks...
Yes, mine too. Therefore, the FDA required the crossover, but the requirement was based on the NWBO selected endpoint. So it isn't fair to say the FDA required it, without adding, based on NWBO's trial design. If they would have used OS, like they should have, we wouldn't be in this boat. It all boils down to a flawed trial design and the blame cannot be assigned to the FDA.
What are all you longs going to do if NWBO has to say sorry even though the OS for our trial seems to be showing some benefit compared to historical norms, the FDA will not grant approval as they insist they must maintain integrity for all current/future clinical trials by requiring the survival benefit is evident as compared against a control?
Are you all going to shake your fist at the FDA or write your local congressman? Will you start to realize that maybe it was legitimate longs (big fish), rather than a short conspiracy, selling their stakes after the LL presentation/warning of trial problems?
Or are you going to play ostrich and maintain that AA is going to happen any day now and continue to blame everything on AF, Phase 5, and Woodford? Just curious...
Do you find it odd that the FDA required crossover for NWBO, but did not require it for CLDX or BMY's GBM trials? Why do you suppose that is? Do you think it had anything to do with NWBO's proposed trial design?
You forgot to mention Mr. Kelley and the investigation he is performing for Woodford. Remember this blurb from the UK article in December? I do.
Woodford also engaged the services of David Kelley, a New York lawyer with a fearsome reputation as the scourge of the Mafia as well as corporate criminals.
Kelley’s CV includes prosecuting murder and racketeering cases involving each of New York’s infamous Five Families of the Cosa Nostra.
I hate having to correct misstatements. I didn't say 300+ were enrolled in two years. I said many of the 300+ were.
I agree with your opinion that the company and investigators are not blinded to much of the trial. I will go ahead and speculate that whatever the reason for re-sizing the trial and PFS threshold, it had something to do with their ability to analyze certain trial data. I'll leave it at that.
The possible "problem" with the pseudos is that they might be contributing to events when in reality their progression isn't valid and shouldn't be counted. Why would this be any more of a safety concern than true progression? I don't believe it would be. Both would be marked as an event and the patients crossed over. There wouldn't be any safety concerns flagged by these events.
The prior DMC review had nothing to do with efficacy. The 1st IA (which likely occurred last summer) was the first opportunity for an in depth review of efficacy. The trial was halted by NWBO shortly thereafter. My opinion, as idiotic as it may seem, is that the trial complications were identified at the 1st IA.
"this trial has been enrolling off and on for nearly ten years now. If this were that big of a problem, then they would have hit the requisite number of events a long time ago and would have re-designed the trial.
I'm not so sure. First, the enrollment ramp has been such that many of the 300+ were enrolled in the last two years. Second, have you forgotten that they did re-power the trial? They knew in 2014 that the PFS hurdle was going to be very close and lowered the bar.
"But no, that is not what happened. They were getting so good of results from the Phase II that they decided to move directly into a Phase 3...you don't do that if people are appearing to progress shortly after receiving the vaccine."
Phase 1 and phase 2 were small samples comparatively. Some of these issues were probably not visible until they achieved a larger cohort in phase 3.
"It may simply be that they are waiting for the subgroup data to mature...that and the longer the trial is blinded the higher the probability of reaching statistical significance amongst primary and secondary end points."
If the overall group PFS data is strong enough to file for approval why wait for a subgroup analysis?
"They really need to hit their PFS target...because OS is going to be highly confounded by the addition of other treatments and the deviations from SoC..."
This I agree with. Everything is riding on their PFS target. And we have been cautioned about "havoc". Make of that what you will.
At first glance, PFS seems like an acceptable endpoint. But this trial highlights how other variables like pseudo progression, etc., can introduce additional unexpected complications/risks into the trial data.
OS seems like a much more solid endpoint to work because it it less susceptible to unforeseen issues. Patients are either alive or deceased and the survival benefit is there or it isn't. There are no "interpretation" issues with OS.
Of course you can still have other supporting measures as well (PFS, immune response, QOL, etc.), but the primary measure for many reasons should be OS.
Do you think IMUC will see a nice bounce if they once again become the leader in the race for GBM approval?
Yes, but there have been many warnings about this trial using PFS vs. OS for the primary end point and complicated further by the unusable secondary endpoint (because of confounding issues). All valid concerns which were quickly dismissed by the majority of this board.
At least this trial will be a useful reminder for future companies/trials that the gold standard has been and continues to be OS for trial design. Also an important lesson for investors new to biotech (like myself) how one little flaw in trial design can jeopardize the whole mission. Actually jeopardize the entire company for those with a limited pipeline.
I feel like everything is slowly coming into focus and for that I am grateful. Not the result I was hoping for, but final resolution will make it possible to move on to other opportunities.
Maybe the current price reflects an updated probability of success by the market with the many new uncertainties and hurdles that must be overcome. This as opposed to big pharma or deep capture type conspiracies. Just a thought..take your pick.
How do you all like our new norm for volume?
"Pseudo progression wreaks havoc with trials"
So, why does Dr. Bosch believe this? Has he had any first-hand experience with clinical trials where this occurred? I think the answer is a resounding yes and is one of the missing pieces to this whole mystery.
Hmmm...why don't you go ahead and poke a few holes in it?
Some here have asked for my opinion regarding the current partial clinical hold status of the L trial. It goes something like this..
IMO, the biggest clues come from Dr. Marnix Bosch and Dr. Linda Liau.
1. With regard to the primary end point of PFS: "Pseudo progression wreaks havoc with trials" -Dr. Bosch. It is my opinion that the 1st IA has occurred and the PFS analysis did not predict a likely chance of reaching statistical significance..
Then we have another clue from Dr. Liau.
2. With regard to the secondary end point of OS. "it seems like everyone’s living longer than we would be expecting" -Dr. Liau
If it were not for #2., this trial would likely already be dead in the water IMO. Instead everyone is left scratching their heads trying to figure out how to move forward and deal with the confounding issues surrounding OS, etc., since there seems to be a survival benefit from the treatment. Thus the 6 month delay from the 1st IA. I have a feeling the final conclusion might be to go back to the drawing board and initiate a new phase 3 trial.
With regard to Linda Powers. She is focused on trying to figure out if a certain number of investors became aware of the confidential 1st IA results before anyone else (remember the 30% intra-day drop?) and profited by shorting it down to our current levels. It would be very interesting to know if any sensitive information was communicated or "leaked" around that time. I wonder if anyone (or any group) of investors had a spontaneous "bad feeling" about the stock around that time?? Anyway, it would explain bringing on the CIA investigator specializing in the area of cyber intelligence. But like everything else, who knows..
NO. As much as you want to dismiss these questions and sweep them under the rug, they are very hard to figure out without any explanation from NWBO. Per Linda Powers, the Phase 2 trial was supposed to start the fall of 2014. It didn't. Yet NWBO received the better part of 100 million dollars from Woodford from the fall of 2014 through 2015.
So, my question stands and can only answered by Linda Powers. Why didn't the Direct trial start in 2014 as projected? What happened to all the money raised during the last year, and why wasn't it used for Direct Phase 2?
It has been nearly 6 months since the partial clinical hold was implemented without any news as to why. It is likely that the trial is not fully enrolled and will never reach full enrollment without additional screening.
It has been 14 months since Linda Powers said the Direct Phase 2 trial would start "soon". We have not received any explanation as to why the Direct trial has been delayed for so long. The longer we go without any news, or any progress, the more likely IMO that there is a significant problem preventing NWBO's trials from continuing.
What happened to all of the day traders? In your experience, what typically happens when volume dries up like this?