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Bear, please note, I have added a small edit to my previous post after you replied. You might want to take another look at my previous (now edited) post. And yes, i was actually primarily think of the Direct PI as well as the ovarian data.
Bear, this is a great find, and I think it provides a full map for the applications to be made by NWBO to the FDA resulting from the PIII in GBM. It is very conservative and yet allows for a broad reach for approval for all solid cancers based on these PIII results.
First submit the standard BLA made for nGBM and rGBM based on the PIII done in GBM.
Then as per this provision NWBO should also submit a second BLA application for all solid cancers based on the same PIII in GBM as suggested in the FDA guidance "to seek a tissue agnostic indication in a supplemental application following initial drug approval in one or more specific cancer type(s)" with some results, as you suggest, from other solid cancer tests already done by NWBO as suggested in the FDA guidance "The supplemental
129 application for a tissue agnostic drug indication should include data in subjects with cancer types not studied in the initial tissue specific indication(s)"
I think this is great news and has the possibility to speed things up by many years to the $1000 per share future for NWBO if things go well. This is nothing less than an invitation by the FDA to follow this path.
Finally I would add an analogy to a prosecutor who has a very good case for murder in the second degree, but decides to try for a murder one trial which he risks an acquittal, and risks losing the murder two guilty finding. Here, simply filling directly a BLA for all solid cancers might risk losing approval due to the over-reach from the GBM trial. But by filing first just for GBM and then a second submission for all solid cancers on the same data avoids the risk of losing the GBM approval on its own, even if the larger ask is denied (which of course I hope will also be approved based on this guidance)
Yes Bear, I agree with you. That was then, and this is now. At that time (but only as small PI of Direct) they did what I suggested. Now that they have PIII results in GBM, they are doing what you suggest and I fully agree with. It is all the same idea. It is one PLATFORM, with one and the same MOA for all cancers so this PIII can be taken as prove that it works in SOLID CANCER, not just GBM as proposed in the new guidelines issued by the FDA. They should approve and follow with P4s for the various indications.
Skit, I agree, if the FDA were to grant a blanket approval for all solid cancers, I have little doubt that they would require follow-up PIV trials to follow up in a well organized fashion how well the treatment works in each of the indications. This of course would be important for further treatment development for each indication. This would far superior than trying to glean in an ad hoc fashion whatever information can be obtained from any off label use by Dr's in a chaotic and disorganized fashion.
I should note that when I posted on Oct 31, and Nov1, I was unaware of the guidance passed in October 2022 concerning
A tissue agnostic oncology drug [that] can therefore be used to treat multiple types of cancer (e.g., colorectal, thyroid, and breast cancers) with the targeted molecular alteration (e.g., either the same targeted molecular alteration or targeted molecular alterations affecting a single pathway)
But the idea is just plain common sense!
Imagine if the FDA approves DCVAX for nGBM and rGBM but then for technical reasons the FDA insists on many long trial for all of the other solid cancers which would delay cancer treatment with the safe DCVAX for many years or decades and which then prove out and eventually gain approval after many lives lost and many billions expended in the duration making the treatment that much more expensive! Imagine the outcry!
Copies of my posts expressing this same (similar) idea in my posts on Oct 31 and Nov 1, 2022:
hankmanhub
Re: Doc logic post# 526352
Monday, October 31, 2022 3:19:54 PM
Post#
526484
of 540456
I am no expert, but in my lay opinion, only one trial should be needed to gain approval for all solid tumors of any type.
Can we not ignore the differences between the cancer's location and focus on the similarities and design the trial such that say a minimum number of persons will be treated for each named cancer and above that minimum they could enroll any cancer type as may wish treatment to fill the trial. This could simply be thought of as a trial for treatment of "solid cancer," without any further adjectives or sub-categories.
So for example perhaps the trial could name say 20 (not rare) solid cancers, and perhaps have trial size of say 1000. Then they would have to enroll at least say 25 of each of these types of cancer in the trial. That would be 500 patients, and the remaining 500 could be of ANY solid cancer without respect to cancer type.
I would suggest that a good response to this sort of trial should merit a global approval for all solid cancers (even beyond the 20 named cancers) without taking years of trials, and huge expense, for many lengthy trials in every solid cancer type.
I am sure many will say this is not the way of the FDA. And I say why the heck not. If in fact certain cancers will not succumb to the DCVAX treatment that will be seen by following the treatment for the first several years to see if there is no effect on certain cancers. In any case even then at least the DCVAX is safe and does not cause any harm.
hankmanhub
Re: biosectinvestor post# 526487
Monday, October 31, 2022 3:38:22 PM
Post#
526500
of 540465
I understand where you are coming from. Sure there will be differences based on the organ in which the cancer finds itself and presumably there may be differences in what is required to treat them. But I suggest it is worth a shot that the similarities IN MOST solid cancers will allow them to be treated by the same PLATFORM without problem even if several may not (or may need some further modification to the same basic protocol). Say some 16 cancer types respond well to this treatment. Why delay approval for use in these 16 cancer types for many, many years?
In separate trial it may take many, many year, at huge cost, and those waiting with type X cancer, may have to wait for 10 to 20 years before we even get to trial for variety X cancer.. There would clearly need to be some sort of follow up procedures to determine which if any cancer types are not responding to this treatment and drop them from the label. But I believe that the greater good is for much more rapid approval and treatment for those cancers that respond well to the treatment (hopefully most solid cancer types)..
hankmanhub
Re: biosectinvestor post# 526590
Monday, October 31, 2022 10:28:18 PM
Post#
526607
of 540466
I have no quarrel with what you wrote. But just imagine if there was no aspirin and it just got invented today, This is a treatment that reduces high fever (among other things). If they now ran trials to put aspirin on the market as a treatment for high fever, would they have to run a separate trial for each indication wherein fever occurs - a very large number of possible causes of fever? Or simply run one large trial looking at fever as a single problem they wish to treat and disregards the differences that may exist for the purposes of this trial. I understand this a very imperfect analogy, but I think it crudely makes the point I wish to make - and not differentiate between a fever in a flu patient versus a fever in say a covid patient or any of the other multitude of causes of fever.
hankmanhub
Re: biosectinvestor post# 526628
Tuesday, November 01, 2022 9:21:40 AM
Post#
526669
of 540466
Of course there are differences, a major one is cost. I was making a point about the basic principle. Like I said, aspirin is a a very imperfect comparison. I was just using it to illustrate the basic point I was making.
Don't fret too much. The writing is on the wall (JAMA) and it won't be long now for the correction to happen.
LIKE I SAID J/A IN THE FACE OF DILUTIONS ARE A NONEVENT.
in any case, if I am not mistaken, management warrants and options are now suspended.
tryn, I think that a partnership on such a short time frame is bot in the cards. Go for something that could actually happen by Dec 30. If you really insist on what you asked for, you probably should sell your shares. What you are asking for will likely come - BUT NOT ON YOUR TIME FRAME.
LP and other insiders could convert their warrants into shares to raise their voting percentage. Albeit, a cashless conversion would mean less shares for those that choose that option.
Note the shorting pattern i posted about - all immediately on very good news:
PIII trial completed - reaction short in response to the good news to cap SP.
Meet endpoints May 10 - reaction short in response to the good news to cap SP.
Manuf progress in UK - reaction short in response to the good news to cap SP.
Presentation at SNO - reaction short in response to the good news to cap SP.
JAMA article with peer review - reaction short in response to the good news to cap SP.
ASM announced - reaction short in response to the good news to cap SP.
This is the only play the shorts have left, and it is proving more costly as time moves on and only provides temporary capping.
The shorts know that time is working against them and every day, is another day closer to DCVAX becoming the SOC for GBM and later hopefully the SOC for many solid cancers. They have only one play which they use consistently, whenever there is good news, Sell short bigtime the next day to force the SP to retreat due to massive shorting with an accompanying hit piece to make it appear that the news is not really good or good enough.
Of course if you sell short enough shares, you will cause the SP to retreat for as long as the shorting continues and new buyers knock at the door again to buy bargains,
This is the recurring short theme, but as the news gets better and better this will cease to work as the selling will become more and m ore expensive until they throw in the towel on the news they can no longer fight, such as multiple approvals from the RAs etc., and eventually news of JV, or partnerships or an actual BO down the road.
only bullet left is a full-throated an ounce t of BLA submission, JV or partnership! With results out, why isn’t a BLA submission in progress?
Only stockholders of record on our books at the close of business on October 31, 2022 will be entitled to attend and to vote at the Annual Meeting and any adjournments or postponements of the Annual Meeting. For 10 days prior to the Annual Meeting, a list of stockholders entitled to vote will be available for inspection at our principal executive offices located at 4800 Montgomery Lane, Suite 800, Bethesda, Maryland 20814.
I beg to differ. The setting of the ASM date and the promise and anticipation of more good news over the next 33 days leading up to the ASM should IMO have a very positive effect on the share price. The shorts are getting to understand that this is for real and not going away. They are going to have to learn to live with this reality. They had it good for a while, but the easy money is gone for the shorts. We should also have news from the UK any day as well that will be a major push for the longs and of course the always possible partnership announcement. I do not see this going down as a result of the ASM, but of course the manipulators may go for one more try, but I doubt they will have any serious success again like they did on May 10 (which btw, did not succeed to kill off NWBO).
If "For NWBO the outstanding FTD number is ... under 10k" then I hear you. But if the number of naked shorts are really large as say 500 M to 1 B shares as NWBO seems to think then it seems we have a large problem to deal with. I am hoping that the NWBO lawsuit materializes soon. This might help solve this problem.
Right on!
I do not agree. This was a soft bash as per my previous post.
This is NOT a positive story. It is a soft bash. It leads with "People who got the treatment had double the average survival rate — but the results aren’t as clear as they seem."
Then it continues to quote Donald O’Rourke, a professor of neurosurgery who was in the STAT hit piece by AF with his false conclusion. then it quotes Merit Cudkowicz, the chief of neurology that this was a "post hoc analysis." Finally it concludes that : "To find out, though, Northwest Bio will need more trials, designed in such a way that the results are indisputable.
This is definitely a soft bash - not at all a good article about DCVAX.
Nope, the markets are open on Dec 30 2022. The Bond market closes at 2:00 PM that day.
2022 Stock Market Holidays
Date Holiday NYSE Nasdaq Bond Markets*
Monday, Feb. 21 Presidents'; Day/Washington's Birthday Closed Closed Closed
Thursday, April 14 Maundy Thursday Open Open Early close (2 p.m.)
Friday, April 15 Good Friday Closed Closed Closed
Friday, May 27 Friday Before Memorial Day Open Open Early close (2 p.m.)
Monday, May 30 Memorial Day Closed Closed Closed
Monday, June 20 Juneteenth National Independence Day (Observed) Closed Closed Closed
Friday, July 1 Friday Before Independence Day Open Open Early close (2 p.m.)
Monday, July 4 Independence Day Closed Closed Closed
Monday, Sept. 5 Labor Day Closed Closed Closed
Monday, Oct. 10 Columbus Day Open Open Closed
Friday, Nov. 11 Veterans Day Open Open Closed
Thursday, Nov. 24 Thanksgiving Day Closed Closed Closed
Friday, Nov. 25 Day After Thanksgiving Early close (1 p.m.) Early close (1 p.m.) Early close (2 p.m.)
Friday, Dec. 23 Christmas Eve (Observed) Open Open Early close (2 p.m.)
Monday, Dec. 26 Christmas Day (Observed) Closed Closed Closed
Friday, Dec. 30 New Year's Eve (Observed) Open Open Early close (2 p.m.)
I never really understood how voting works if you have a very large number of naked short sales. Presumably all (most) of the buyers from the naked shorts are unaware that their shares are not actual shares entitled to a vote and will presumably try to vote their shares just as any "legitimate" shareholder will. So when the company receives votes for say 150% of the outstanding shares, how do they adjudicate which are the legal votes and which to discard? If they can not distinguish, which is which, will that invalidate any vote at an ASM?
Same question for a BO. who gets money from the buyer as holding legit shares and who does not? In this case the shorts would probably be forced to cover or their brokers will have to pony up. But this does not happen for a run of the mill ASM vote.
Thanks for trying.
Exactly who told you that??
f you told me 3 years ago we would have such a strong paper in Jama I would go crazy. If you then told me what the SP would be a week after publication I would never believe you. I would take 4-5 dollars tomorrow in a buy out and never look back.
Perhaps I should have been a little clearer. I did not mean to suggest that the current share price or anything near that would be seen as an acceptable deal price. Surely no investor would accept anything close to today's share price. But if the deal read something like say a 20 or 40 multiple of the average closing share price of the previous ten days of trading.
But I see the issue you were pointing to, and the reason you were pointing to something like potential revenues and EBIT or EBITDA.
ATL, that is great info. Thanks. Can you per chance post similar information for rGBM?
I have another thought (speculation) on the trading battle we are seeing daily shortly before closing. This is mere speculation. Why are they so concerned if the close is half a penny up or down? In the big picture this should not matter very much when we look back say a year or so from now? Consider if NWBO has a major PR to make about now, BEFORE announcing the ASM. What if this is the announcement of some sort of partnership deal or even a BO they have been waiting to make shortly after the JA publication which has just happened big time in JAMA! One more "what if." What if the terms of the deal made was tied to the average closing price say of the last 10 days prior to the effective date of the deal. Now we have major interest on the part of the buyer BP to force the price as low as possible before closing each day. Literally BILLIONS of dollars can depend on these closing prices even if the actual value of these before-closing trades dropping only a penny or two is only a few tens of thousands of dollars, if that!
I suspect that many of you have already noticed this as it has been going on now for quite a while. The trading bot (or human) dog the trading for the shorts, has a cute ploy that is probably well know but quite effective. When there is some buying strength showing on the Bid, with a Bid Size say between 25K to 50K say at .86 for example. The sellers do not want to show bidding strength, so they "remove" (hide) this by simply entering a "higher" bid at .8601 with a Bid Size of only 1K and poof, the bidding strength has been disappeared like a magic trick and is not visible anymore to most. The same can happen in reverse on the Ask going from say ,86 to ,8599. Clear manipulation in a poorly regulated market like the OTC. I might add, that this is rigged in favor of the MMs. They can place a bid or sell at say 8601 or .8599 while the retail investor can only place their bids to three decimal places such as .861 or .859! This always puts the MM's bid as first in line, ahead of the retail investor, due to the fourth decimal place!
You've got it exactly right. The share price goes down in response to the manipulative selling by the cabal, NOT in response to the content of AF's article that no one believes anyway. Like you posted, he is merely either a "cover" for their selling, or more likely, he is the signal for all parts of the cabal to start the selling.
The LL presentation at SNO was on Nov 20 - not Nov 23. Probably a minor typo.
It is not AF who did the damage today, but the major shorts who pull his strings. Unfortunately their ability to short does not need to fade away like the influence of the AF article. Hopefully, they will choose to allow the inevitable to happen as more PRs drop from NWBO.
Paying generic companies to keep generic competitors off the market is not right but it does not compare to what you are claiming, which would be keeping science innovation off the market.
Follow the money - they stand to gain big time by this shorting activity. They may not do this for your run-of-the-mill small bio, but this case may be a one in a lifetime event. They definitely want a big piece of this pie.
I agree with you on this. Wish you luck in trading in the fresh air and stars on you park bench, for the stale air of heated/air-conditioned space indoors.
AF is not "successful" at all. The success is that of the major shorts' power being well funded. This is not simply a retracement. it is to sharp and well coordinated to be a sell on news. Now after the JAMA article, we will not see an 80 million share short mounted by the shorts as even they see the writing on the wall and will not get in that deep again, but they do hope to cap the stock in hope of a better deal at the bargaining table when they try to deal with LP for a piece of the pie.
AF's hit pieces do not convince anyone - all know he is a fraud. They merely signal the start of the short attack by the interested major shorts.
AF is not the cause for the shorting - he is the symptom of the shorting. Follow the money - and it leads to big BP! (not AF).
Fully agree!
No you're wrong. It is not just "one bogus article is published in a bogus rag by a bogus reporter." It is because of some determined major shorts (MM, BP and Venture Funds - very few actors in control of huge funding) who will lose billions in revenue id they do not succeed in capping NWBO and take it over cheaply. I think they all know that backruptcy is not on the table anymore.