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Correct. But please call anytime you would like. We would love to talk to you. LMAO. Let's be honest. No response from email, no response from phone calls. Very comfortable salary to be the PR guy.
Cool, why don't you share your recent conversation. Did he seem frustrated, upset and Curt?
Happy trails Flipper. Thanks for all of your efforts to boost confidence at just the right moments. The 1st IA run-up in 2014, the HUGE Germany HE and PIM designations, the spectacular Direct data, the AA scenario and then the FDA has stopped for efficacy scenarios as the stock dropped from $12.55 to $1.25. Yikes! But you have worked hard over the past few years and I think your sentiment successfully resonated with many folks here. The kind that blindly read stuff and repeat it without fact checking (a few examples of it just this morning). The move up to $12.55 was a pretty darn good little run for a penny stock reverse split so many time. Anyway, why don't you take a little time off and celebrate a job well done. Cheers!!!!
Oh man, I thought it was Woody buying more. Dang it!! Guess maybe the rocketship isn't ready to launch just yet. Do you think maybe the "hold may never be lifted" risk disclosed recently might just put a damper on his plans to flush more money? I sure hope not..
Looking good, looking very good!
Interesting article from a few days ago.
http://internetmedicine.com/2016/03/25/48727/
"Glioblastoma is universally fatal, said Fred Hutch neurosurgeon Dr. Eric Holland, whose brain cancer research team focuses on this tumor type. Patients with the more aggressive form of this cancer have a median survival of about 15 months following diagnosis, even with the standard-of-care treatment.
Right now, the standard treatment for glioblastoma is a combination of surgery, radiation and chemotherapy. There are few options when those fail, but Holland is cautiously optimistic for the future. He believes with an as-yet-to-be-determined combination of immunotherapy and precision medicine, brain cancer researchers may finally make some headway against this long intractable problem.
“For a long time this has been a very hopeless field. A lot of people who were in it were either idealists who were imagining somehow changing the world — or nihilists who knew they couldn’t. It’s been a very hard problem,” said Holland, who puts himself in the idealist camp. “But all that said, I think there actually is a crack in the door right now.”
I've always enjoyed your posts Eval. One of very few. I know you call people out, long or short. I appreciate that quality.
I'm not trying to come up with more negatives, just processing data as I find it. Today was the increase in SAE's. Yes, that's a check in the negative column, but it's factual and it was new info. I also postulated that NW might be buying again, although total speculation, which would be a positive indicator for longs, so give me a little credit :)
Jeez Eval lighten up. All we can do is speculate. We have been in the dark for 8 long months. I'm ready for day light and an explanation as to what the heck is going on. Just tossing ideas around on a message board. Did something I say annoy you?
He's got big balls. Don't know if they are crystal. Probably nothing more than a similar look/feel to when he was buying open market before. Guessing these are dark pool buys that process at end of day. Also consider his recent public comments about investing more in cutting edge health care. He buys more, I buy more. So + 1,000 shares to whatever he adds.
How many exactly traded at the close? It seemed like we were at 300k something leading up, didn't really pay much attention the last hour, and now it's showing over 700k vol. What up with that?
Weird, I haven't seen activity at the close like that since Woodford was buying blocks last summer.
Okay here's a weird theory, yes I have a bunch so shut it. Senti has speculated that NW has been under a NDA since last October after his face to face meeting with management. The idea is that he was given information that prevented him from trading. Recently, the company disclosed that the hold may never be lifted. Today, they released a presentation that included an increase in the SAE's of the L trial over what was previously reported. Maybe he felt this disclosure was adequate to allow him to buy again?
Well then we need some size buyers to push it higher. I'll get on the intercom and take care of it.
Woodford, please report to the Ask, Woodford to the Ask..thank you.
What's with the trading range at 1.50 to 1.51?
It may be a much more ridiculous scenario than say something like AA, but did you happen to see my example from earlier about a partial clinical hold imposed for a safety issue?
I know when the hold started. If it were for possible SAE's or safety, it may have taken them until sometime after Jan 2016 to determine (or admit) the new ones that are related to the L trial. Back to where we started. 7 SAE's noted as of Jan, 12 as of Mar.
As you previously said, the SAE's likely occured sometime prior to either date and at some point they felt it was necessary to update the number. Maybe they occured sometime around July or August? We don't know. So stop trying to rule out with certainty the unknown.
To this day they might maintain that these were only "possibly" (at worst) related. And it isn't the first time it's happened in the trial. So I'm sure they would be comfortable saying that they weren't aware of any new adverse issues. Maybe SAE's are just normal occurrences and don't constitute material information. I still think that multiple SAE's in close proximity, depending on severity, could be enough for the DMC to say hold up a minute while we investigate. Maybe a bad production batch or something. Is it really that far of a stretch? To you and Senti probably..
Also, in your post to Eval, you said the enrollment was at 300 in Aug..blah blah blah trying to show it increased. But you are wrong. From the PR on Aug 21st.
"Over 300 patients have been recruited for the trial. The total anticipated enrollment is 348 patients."
So scrap that and start over. We've gone from over to 300 to over 300. Or aka still some unknown number in between but not 348.
"Makes no sense to even speculate about what that number is at this time, IMO."
Maybe not to you. But if there was a recent (within the last 8 months) increase in SAE's specific to the L trial, don't you think that may be pertinent information to anyone trying to figure out the reason for the partial clinical hold? The increase (whatever the number) seems like a possible clue.
Didn't they stop enrollment in October. Maybe it took a few weeks to determine they had a few SAE's in close proximity that were "probably" related to treatment.
I don't think it's that black and white.
How many of the dozen or so do you think have been determined were "probably related"?
Darn those little errors that you find while your trial is under a partial clinical hold. If it comes out that the hold is safety related, it's over. People are licking their chops just hoping they were that stupid.
January 26, 2016 DCVAX L "Over 400 patients treated, with over 2,800 treatment cycles: only 7 “possibly or probably related” SAEs"
March 30, 2016, DCVAX L "Over 400 patients treated, with over 2,800 treatment cycles: less than a dozen “possibly or probably related” SAEs.
Did you expect this number to nearly double in "such a short period of time"??
Looks like more good news that people will turn into bad. Read the above and then read the below. Is the blurry picture starting to come into focus?
"our Phase III trial of DCVax-L is on a partial clinical hold for new screening for enrollment. We do not know what will happen with this partial hold. Although we have over 300 of the planned 348 patients already enrolled in this trial, and they have continued to be treated without interruption, we may not be released from the screening hold and may not be able to complete the planned enrollment"
"Less than a dozen “possibly or probably related” SAEs" Is that new? Possibly or probably...really wtf, which is it??
Something has gone terribly wrong IMO. The share price already reflects it, but we haven't found out about it yet. I think we will relatively soon and then we will feel like total idiots for not getting the F outta here long ago when everyone else did. Yep, a PR person who gets paid big bucks to let his voicemail get full and not issue any correspondence about anything.. Pretty cush job.
Example of a partial clinical hold (like the one L is currently under) and the surrounding events.
October 10, 2015 - "Zafgen recently learned of a patient death which occurred in the Company's ongoing double-blind, randomized, placebo-controlled Phase 3 best PWS study of beloranib in Prader-Willi Syndrome, a rare genetic disorder with a high rate of mortality linked to obesity and its co-morbidities. The cause of death remains unknown at this time. According to normal practice, the event was reported to the U.S. Food and Drug Administration, at which point the Agency initiated a discussion with the Company. The Company is working with the Agency to expedite a review and understanding of this event, and to determine implications of the event on the conduct of the trial, and anticipates providing an update as its discussions with the Agency progress."
October 16, 2015 - "Zafgen a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that it received verbal notice late yesterday from the U.S. Food and Drug Administration (FDA) that beloranib has been placed on partial clinical hold. This partial clinical hold impacts ongoing or planned clinical trials, including ZAF-311 and ZAF-312." (notice, they had multiple trials put on hold due to the safety incident in the one trial)
October 22, 2016 - "After review of its ongoing clinical trials, the Company has elected to proceed with efficacy and safety data analysis and close the randomized portion of its Phase 3 ZAF-311 clinical trial of beloranib in patients with Prader-Willi syndrome (PWS) and its ZAF-203 Phase 2b clinical trial of beloranib in patients with severe obesity complicated by type 2 diabetes. Zafgen believes that a sufficient number of patients have completed randomized treatment in both clinical trials to assess the efficacy of beloranib and help inform next steps for the beloranib program. Following the partial clinical hold announced last week, the Company believes it can best preserve the integrity of the data in each clinical trial by closing the randomized portion of the clinical trials early. The Company, based on consultation with the U.S. Food and Drug Administration (FDA), expects ZAF-311 to remain a pivotal clinical trial.
In consultation with the FDA, a full assessment of the safety and efficacy data from ZAF-311 will be performed to inform the design of ZAF-312, the Company's second PWS Phase 3 clinical trial. The FDA has informed the Company that it will review the ZAF-311 clinical trial results on the basis of an abbreviated data package. (hmm..dialogue with a regulatory agency and submitting a "data package", sound familiar?)
Who knows if this is similar to what's going on here. But for everyone who posted that a partial clinical hold meant we could definitely rule out this being a safety issue, well here's an example of a trial placed under a partial clinical hold after a patient death.
Here's a question for the board with regard to the requirements for the release of material information. If a company were placed under a partial clinical hold for a "safety incident", but the company strongly disputed the fact that the incident was a result of their treatment and believed instead that it was due to natural causes, do they have to report the incident as a company material event? Is this a gray enough area that someone could make a case for maintaining silence and that they were unaware of anything untoward? I would probably have to consult with a Harvard lawyer on this, but thought I would throw it out for discussion.
I don't usually read the board with all of the yahoos, but read this last night from one of the bulls over there who supposedly regularly talks with Les and agree with several of his points.
"The risk that most concerns me is the one in re that the halt may never be lifted. There are a number of positive explanations i.e., that it is fully enrolled, that it is not but the pipeline is sufficient to complete enrollment, that there are sufficient enrollees now even though 348 have not been reached, that it has been halted due to efficacy and compassionate considerations, that they are focusing on a sub-group and waiting for events to mature, confoundment with cross over and evaluating OS, which are all rather positive and do not represent adverse risks. These all could be associated with faster approvals. The only risk I see here is that the trial continues to the end. So the risk is with disappointment with lack of faster approval and while this is not bad news, it has nothing to do with whether the halt is lifted or not as an adverse risk.
Rather, not lifting the halt as a possibility is ominous as it connotes the possibility that the trial may not be completed, that the trial may be yet enlarged or changed somehow implying yet another delay. This delay could be ominous in that it could be for a significant period of time. Devastation of the share price from such a revelation. Thus, the connotation is that temporary halt which has a risk connoting adverse could be bad or potentially so.
The issue I have is that this POTENTIAL at the very least is MATERIAL and should have been disclosed much earlier. Silence has devastated the share price and further bad news would compound it. Because of the delay in revealing what is going on (bad news or its potential), the pps will be further whacked. This could have been somewhat avoided thru earlier revelation and allowed shareholders to assess the situation before the precipitous devastation.
Secondly, Les and NWBO have made a number of statements that would lead investors to believe and reasonably so that there was no bad news or potentially bad news related to the temporary screening halt. To now state that the temporary halt as a risk may never be lifted now obviously calls for serious concern that something is wrong with the trial and/or it must be modified in some way or even redone all implying possibly significant delay. This is bad news. Or potential for it.
I hope it isn't. But if it is, NWBO has opened itself to serious liability. First in failure to disclose a material fact sooner and secondly misleading investors. Can NWBO defend? Yes, but that is not the point. Serious, and not ambulance chasing, suits will undoubtedly arise. Senti, trust me, if that happens, NWBO is cooked. I have known Les pretty well for a number of years. I had no problem telling him this. Credibility will be completely lost, and probably a change in management will be sought. Not good for the share price and NWBO will surely become a penny stock. The risk revelation to cover their behind is ominous and I assure you, it won't mitigate the significant force of suits against them if bad news plays out. Let me be blunt, Senti. It smells." - Drummword
"I believe that with what NW gave them in October, and the two other very undesirable financings they have done since then, plus the warrant packages built into the last financing, they ought to have enough to see the trial to the end"
Cash at 12/31/15 = 22m
Accounts payable at 12/31/15 = 17m
Conservative estimate of 2016 monthly cash burn = 5m
Zero cash at Feb 2016 = toxic financing.
The 10m from the last financing should keep the lights on for another 4 weeks or so..
With regard to your response to my post. Why not just set the record straight? Call Les, ask him if the current partial hold is in any way related to the investigation. Then ask him if Linda Powers presented today at the World Vaccine Congress and if not, why not. While you are at it, ask him if enrollment is complete. Tell me Senti. Why would they list the potential inability to complete enrollment as a risk if enrollment were already complete??
Can anyone else confirm this?
Senti even the experts are puzzled by this unprecedented type of halt. Don't you think someone as smart as Smith would be able to figure out if this were nothing more than reaching full enrollment? It's much more complicated than that, as you are aware, but I understand your desire to avoid the more negative possibilities.
Let's think about this for a minute. There could be a multitude of issues that would fall under the category of misconduct. Things not even mentioned in the Phase V report. If a regulatory agency said we won't allow you to continue your trials (yes plural) until certain matters are investigated and resolved, how could this be announced without throwing gasoline on the shorts already blazing bonfire? What would it look like?
Well for L, it means no new patients can be screened. Existing patients can continue to receive treatment since they have already had such invasive procedures done. And what about Direct? Well, phase two initiation grinds to a halt just as we have seen.
So how do we move foward? First we need to find some help. Hello Michael Meehan. One of your areas of expertise is crisis management? Perfect, welcome to the team. Okay, so here's the plan. We need to conduct an independent investigation to resolve these matters, but we can't let on that this is required or tied to our trials being halted, or we are toast. Well, why don't we have NW request it? And how fortuitous, there just happens to be an anonymous report to use as a 'reason' to get the ball rolling. Let's set up a face to face with NW in October to discuss.
Okay, so we tell the authority that we are innocent of any wrongdoing and are willing to prove it by initiating the independent investigation. They agree to the plan and say that continuation of the trials will be contingent on the findings in the final report. This could be considered "dialogue, could it not?
Since the company execs fully believe they are innocent of any wrongdoing, they can publicly maintain that they are unaware of anything fundamentally "wrong" (remember it's all baloney) and of course they don't know of any reason (the allegations are all false) why the stock is dropping like a lead balloon (hey I know Les, let's blame the naked shorts).
Anyway, this is just as plausible as any other scenario. Much more so IMO than anything regarding efficacy.
This is what happens with a company doesn't provide any transparency or explanation after everything completely stops for the better part of a year. The sky is the limit when it comes to theories and ideas as to what's going on. Maybe my hypothetical scenario is a million miles off, maybe not.
With the puzzling and unprecedented nature of the partial clinical hold, it makes me wonder if maybe there is a connection between the hold and the investigation. Maybe the investigation must be completed and reviewed before a decision can be made about allowing either the L or the Direct trial to continue. Maybe that's the missing piece of the puzzle. Right in front of us the entire time.
Wasn't it you the other day stressing the importance one little word can make?
One thing you can't dispute. Woodford isn't at all confident with the current management team. That's why he required an independent investigation and also conducted his own separate investigation by someone who specializes in rooting out criminals.
Right, and the word likely isn't anywhere. Funny the difference one little word can make. Like if I said something could still come good, or if I said it would likely still come good. Do you get the difference?
Thanks Flipper. That's an interesting quote of someone's opinion of what Woodford thinks. Maybe his will help. A quote directly from him.
"With some early-stage investments not everything will go well. It is too early to pass judgment on Northwest, but we have hit a bump in the road that needs to be addressed."
Will you please provide a reference for where NW ever said this would "likely" come good. I remember him saying there would be bumps in the road, and that not all early stage investments would be successful. Please show me where I can find this confident statement you are attributing to Woodford. Thanks
Technology and scientific progress waits for no one.
I can confirm that no PR today means same old song and dance. Please review any of the presentations from the last two years for the content. Enjoy
Sorry Flipper. It appears ARGS is moving forward, whilst the Direct trial has been stalled for the better part of two years. You are correct that they "should be" starting something soon. Sadly, they aren't. The 100+ million they received from Woodford during the last year should have been more than enough to move forward with the phase 2, but it doesn't appear to have been used for that. Nor the money raised in December or February, even though it was reported that was the purpose of those raises. Legal fees sure add up quick don't they??
ARGS is a good example of progress that is possible when you have a competent management team in place. Trials in limbo for months, zero progress after years or promises, legal battles, investigations, toxic financing, well that's a prime example of what you get here. Cheers!
If you only move the carrot through April, you have to move it again in just a few weeks. At least move it through 2nd quarter. That will buy us time through June, at which time it can be moved again. You will still have conferences or events dispersed throughout that can be used as 'baby' carrots to keep folks tuned in. Thanks
Good for you. I usually risk and lose more than I should.
Wow there are a lot of parallels. Very interesting. I wouldn't be at all surprised.
6 months for the investigation dip. It's more like 15 years and 6 months for the clinical trial (status or ability to complete unknown)