I have been think more about the possibilities of partnership negotiations versus bad ability to predict timelines. I think if it just that they are God awful at gauging steps and timelines, they can’t be off by that much. I mean it was less than three weeks ago that LP said September twice in one talk and once on a slide. Thats very near term. So I think if this is the case, then we will hear news by end of next week...no later.

If, however, this drags out beyond next week, then I am very much considering partnership negotiations are afoot.

I am patient. I can give them another week.

I was once upset about the Feb 2017 PR but got over it. There they were very hazy on any timing and have understandably emphasized OS and decided to take the trial out further. As far as the Nov 2018 comments, they were again very hazy, but laid out the steps that they would take before DL. The SAP took longer than anyone expected and DL process was significantly delayed by COVID. I give them a pass on that timing.

The recent foible is a clear miss in guidance. If, however, Occam’s razor is correct and we hear TLD shortly and it is positive as I believe is likely the case, then all will be forgiven.

I am prepared to wait it out. I may even add a little more to my position.

The more I consider the alternatives the more I think about Occum’s Razor.

The simplest explanation is that they just missed their self imposed deadline and are not yet ready to report results. It could be they did not complete their SAB discussions or they haven’t lined up media coverage by LL et al or they just plain moved too slow because of short staff and lack of urgency. As far as pie in the sky explanations, I think partnership discussions is a lot more likely than this Fast Track/AA hypothesis but I don’t think either is very likely.

I don’t think this delay in any way signals negative results. If anything, it signals positive results.

LPs comment about anticipating result in this month of September was written on her slide as well as September being written in two PRs. That’s three official communications spaced 3-4 weeks apart confirming September. Enough said.

Something is brewing. It could be positive like partnership negotiations or negative/neutral like another financing, but I don’t think the delay signals in any way negative results. Just poor communication practices.

Sharpie, thanks for showing us the well lit path ahead of us. There is more than one light at the end of this tunnel!

Hope, I hear you. I was buying heavy back in the $3-7 range (starting in 2013). Not counting stock loss swaps against big wins on $FOLD and $ARRY, I’m into $NWBO for about $650k. Believe me it hurts to see my friends and friends of friends coming to the table because of me and having numbers like 500k shares for $125k investments. I even have a friend that has twice as man shares as me for half the investment, and all because of me. None of them has done the due diligence, they are just riding my coattails.

In the end, when this hits, and baby it will hit big, All of this will be water under the bridge. But for now, I am in this stock deep for all the right reasons, have put blood & tears into it, and have a hard time being patient with management. But, these years have taught me a lot of patience and I know that I am right about this one. When the chips start to fly, I too will be able to retire and because of big wins on $DNDN, $KERX, $FOLD, $ARRY and a dozen other modest Biotech wins I am not too nervous about this investment.

Here is to the longs that have been here a long time. We deserve to reap the rewards.

Hi Ski T, You are thinking of a partnership placing a high emphasis on NWBO stock valuation, but in most cases partnerships are entered into with little to no equity stake.

In my view, NWBO should be looking to partner with multiple BPs dividing up therapeutic areas. This protects them from takeover by any one BP. It is typical (see IONS) for bios to actually protect themselves in this manner by putting poison pill clauses into the agreements that cause a hostile takeover candidate to lose assets to current partners. Obviously the first partnership would entail CNS tumors starting with GBM, and the next would likely be Genitourinary tumors starting with Ovarian CA. Follow it up with GI tumors, Endocrine tumors, and on and on. The best strategy IMO would be to take cash upfront, with milestone payments for INDA approvals, reg submission, reg approval, etc. Generally these partners do want an equity stake in the neighborhood of 5% which would help to revalue Our stock while limiting exposure to the scrutiny over stock price that you suggest. Anyway food for thought...

On the topic of some FDA process delaying TLD, I really don’t buy that thinking. I don’t see why the two processes would not run in parallel without one impacting the other in any way. Companies release TLD and submit to regulators all the time. TLD release shouldn’t impact any FDA process. Even in the case where they are arguing endpoints and analysis, you see this too where the data the company rlelease does not match the statistical analysis the FDA wants and ultimately ends up in the label. Investor communications are generally overlooked by FDA.

Anyway, my two pence...

Dave wouldn’t be in the loop. These things are kept very close to the vest until they are public.

Yes, they could sign a non-disclosure agreement so that they could roll up their sleeves and start to talk real numbers.

I am not saying that I put a lot of hope into this theory, But I do think it is plausible. We know BPs came knocking several years back when Direct was getting a lot of attention. Perhaps, they are back.

Actually really funny Ex...I needed a good laugh today

Hi Gary,

I have not had time today to keep up with the board at all and I have a theory that may already have been discussed. Perhaps you can comment.

First, I too am disappointed that the management team set expectations clearly and as recently as September 12th, but failed to deliver. I do not buy the argument made that data lock has not yet occurred or even that it occurred in the past couple of weeks. Data lock happened in August and probably closer to August 19th than August 30th. I am certain that they have data in hand already, but perhaps they have not had time to share with their SAB. Perhaps, they could not line up dates in September to have LL and other KMEs available for media support...who knows. It would have been nice to get the update promised by DI to sort through and explain.

Having said all that I do, however, have a possible explanation that could fit the picture and explain the silence and be very acceptable to shareholders. Maybe they began partnership negotiations with one or more BPs recently and one of these has progressed to the point that the final details are being hammered out. I could very much see that said BP would require NWBO hold off making the TLD announcement until their name could be added to the PR so as to get full exposure. The BP would want some control over the scientific message as well as some credit for the success.

Here is to hoping we find out what’s up very soon!

Dendream

Ditto Sir P!

Glad to hear that you made it through well. Enjoy the painkillers and don’t be shy. Better to be high than in pain.

That was the most undignified performance I have ever seen.

One thing that I forgot to consider until just now, is that when you have big news to release, you have to get one or more Key Medical Experts prepared for a media blitz. Generally, when the news is big enough, you even want to quote the Principle Investigator in your press release. To do this right, you want to pick a day in advance and have a KME in each of the four US regions as well as at least one in Europe ready to conduct interviews with news organizations.

Perhaps, tomorrow is the day and LP has been preparing for this well.

Whether NWBO hits their self-imposed deadline of TLD by tomorrow or not, I don’t think it reflects negatively on the eventual results.

In fact, just the opposite. I continue to firmly believe that they already have data in hand AND that if this data is negative, then they have 4 days to inform me, a shareholder, of this news. Therefore, every day that marches forward makes me more confident that DCVax results in GBM are positive. I have put my money where my mouth is making incremental purchases over the last week. If news doesnt hit before market tomorrow, I suspect a great buying opportunity will present itself and I plan to act.

Very well put, Gary! I agree with your sentiments completely.

If my memory serves, it was RuleofK who put out there that DI implied that the government was the reason for this taking so long. From his post, I replied saying that My guess is that he was referring to this being the pivotal CT and that as such it was subject to significant regulatory scrutiny, not that they were undertaking some new regulatory pathway.

To this he replied and agreed with my sentiments.

No excuse for missing the September expectation IMO.

I don’t agree that there is any excuse for not hitting the September expectation. Yes, they couched their statement to have legal wiggle room should they fail, but they clearly and repeatedly set September as an expectation. Should they have other things brewing with regulators or partners, there is no reason to hold TLD up. Putting out multiple PRs with good news would serve to add multiple gains in SP.

I’m not whining here because I actually do expect they will release results in September and if they miss by a couple days, I won’t cry in my pillow. If they miss by weeks, however, I will lose confidence in management.

7/24 PR “... currently anticipates that Trial results will be ready for reporting approximately sometime after Labor Day in the month of September. “

8/19 PR “The Company currently continues to anticipate reporting topline trial data in September”

9/12 ABTA “unblind, unveil, and release results later this month oF September”

This to me says the company is entrenched in reporting results in September. If they anticipate a delay, these PRs also say they will update us. If we do not receive an update today or tomorrow before the bell, I think it is safe to assume an after hours PR. Not sure why they are waiting until the last minute, but I hope it has been done to trap shorty and build anticipation.

Agios has a rare disease drug with some promise in their pipeline but it won’t bring in a huge rev stream as the space is already looking like it will be crowded. AGIO still maintains a Market Cap of $2.6B. It fell a bit after the news of the near miss on OS and they have a good deal of cash to fuel operations, but I think it is already proof that a near miss on OS won’t mean we are done.

I’m hoping to get an NWBO windfall soon so that I can get into $AGIO, as well as build on my positions in $FOLD, $BTAI, and $VKTX.

Not sure if they have had their pre-NDA meeting with FDA yet. If so, it would be a very good sign that they plan to submit as FDA probably encouraged them to do so. I’m guessing that they have, but milestones like these rarely get reported.

Hey all, here is an example of a Company (Agios) and drug that saw a very positive effect on PFS, but as a result of large crossover only saw a trend in OS. They will be submitting to FDA for approval in Q1. Very curious to see how this plays out. It is my only concern with DCVax, that the efficacy is so good that crossovers benefit greatly and screw up OS. In our favor is the fact that LP let the study go on for much longer than $AGIO did. This should help strengthen the power enough to show a statistical benefit even if the magnitude of OS effect is narrow.

CAMBRIDGE, Mass., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced the results of the final overall survival (OS) analysis from its global Phase 3 ClarIDHy trial of TIBSOVO® (ivosidenib tablets) in previously treated cholangiocarcinoma patients with an isocitrate dehydrogenase 1 (IDH1) mutation. A consistent trend in improved OS was observed in patients treated with TIBSOVO® compared to those randomized to placebo, but was not statistically significant. The OS endpoint can be affected by crossover, so these results should be taken in the context of the large proportion (70%) of patients in the placebo arm who crossed over to receive TIBSOVO® following radiographic disease progression; additional analyses performed to take crossover into account further support that TIBSOVO® may improve OS. The safety profile observed in the study was consistent with previously published data. OS was a secondary endpoint in the ClarIDHy study; as previously announced, the study met its primary endpoint of progression-free survival (HR 0.37, p-value < 0.0001).

“Advanced cholangiocarcinoma is a rapidly progressing, aggressive disease with a grim prognosis for patients,” said Chris Bowden, M.D., chief medical officer at Agios. “The data from the ClarIDHy Phase 3 study show that treatment with TIBSOVO® has the potential to lengthen time to disease progression and have a clinically meaningful impact on life expectancy for patients with IDH1-mutant cholangiocarcinoma. We will collaborate closely with regulators to advance this potential new oral, targeted treatment option for patients.”


“We are tremendously grateful to the patients who participated in this study,” continued Dr. Bowden. “Part of their legacy is their commitment to contributing to medical advances on behalf of others who will face this devastating disease and who currently have limited treatment options.”

The company plans to submit a supplemental new drug application for TIBSOVO® in previously treated IDH1-mutant cholangiocarcinoma in the first quarter of 2021 and intends to work closely with regulators on next steps. A full analysis of the ClarIDHy OS data will be submitted for presentation at a future medical meeting.

Thank you to everyone who passed on information about accessing DCVax. I am speaking with my friend tonight and hope to pass this information along.

Thank you

I just got news that a good friend of mine was diagnosed with GBM on Thursday. Does anyone know how he can get access to DCVax?

$0785 is the new $061

X Master - I agree, if LP was recorded, then the CEO and her team had the opportunity to review and edit for accuracy. I think we get Positive TLD news on Wednesday.

And Anders drops the mic...

I think DI is deliberately kept out of the loop on events that if communicated in one off discussions could present broader problems. I think he shoots from the hip so to speak and is in the business of keeping investors invested and interested, not in the regulatory process business.

DI can’t confirm anything like DL that would put a narrow time frame on their knowledge of the data. As Anders clearly has shown the company must share a negative trial immediately. To confirm DL, would be in essence to confirm a positive TLD.

Spidey - look at post #306718 for a link to the SEC site

RuleofK - thanks for confirming my intuition. This is a nothing burger. Therefore, I remain in the camp that thinks we get TLD this week and that it is positive.

Poorman - I did not speak with him and therefore did not hear his exact words. I don’t think he was alluding to any new process or behind the scenes submission. What I think he was referring to was the fact that this is a registrational trial and therefore subject to a very high degree of RA scrutiny. As well, everything they have to do to prepare the package, from manufacturing inspections to “batch” validations, is all done with RA submission in mind or in process. I think he was just saying that because of this RA scrutiny (i.e., dealing with the government) every step they take must be double and triple checked before proceeding.

One last buying opportunity before liftoff. I plan to wait and see where we level off today before grabbing some more shares. I am confident adding to my significant position because IMHO...

1. Soft Lock likely occurred before September 1st to allow LL the opportunity to complete the SNO LBA abstract submission ahead of the hard deadline. There is no way the company would race to make this deadline for negative results.

2. There is NO WAY that Hard DL has not yet happened. In fact, I bet it occurred within 1 week of the 8/19 PR.

3. DI is likely kept out of the loop on these final stages so that he can’t inadvertently spill the beans. Therefore, any off the record statements he makes should be taken with a grain of salt. Despite this, he did state that an update would be given in the near future to several IHUB members.

4. Stats should take 2 weeks, maybe three weeks at most. Leaving me to conclude that LP has likely had final data in hand for at least 2 weeks now.

5. Which means, LP has passed the 4 day threshold to announce bad news to shareholders, and thus she is sitting on positive data. (Coupled with the SNO abstract, this is a strong indicator IMO)

6. LP confirmed just 2 weeks ago that ago that end of September was the expected timing of the TLD Announcement. Although DI verbally indicated that this was taped, it was likely done so close to the 9/12 airing at ABTA.

7. ABTA audience is physicians, HCPs, investors and even patients so setting proper expectations is extremely important.

8. Flashworks deal

9. Swanton expasion accelerated

10. Desperate short attacks with misinformation

Agreed

Data is double entered into the database and then goes through QC prior to data lock. All site data was locked by Augst 19, so there is little likelihood that the CRO is cause for any additional delay after 8/19.

We are good to go and should hear TLD next week.

Anyone know when the Alzheimer’s study will read out? It should be a major catalyst for BioXcel.

I am SO excited for next week! I can smell news and it’s coming

I agree that there was likely a soft lock in time for SNO abstract submission and that possibly MB and LL were the only recIpients of said data. I am the one who first posted the SNO LBA abstract language on the board and contended all along that TLD was included in the abstract or else it would have been rejected. The language for SNO is clear and they have to treat all comers the same, so there is little wiggle room there.

Wouldn’t it be GREAT to see an after hours PR today with TLD? Personally, I think it happens next week, but today would be soooo sweet.

When the first DNDN short squeeze happened, the stock dropped hard on a Friday taking out all kinds of stop loss orders, and then news hit after hours. Man were those who sold sorry.