Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
pgsd,
Opening a fund and building up NWBO share count there with slow to trade units could help with temporarily avoiding a fail to locate issue for certain folks working in the shadows who would othewise have a more acute problem to deal with. I hope nearly every share is being accounted for now by NWBO investigators with regard to individual owner or institution and trading activity patterns. The funds under scrutiny by this board have stated that recent actions taken against their current practices would necessitate the use of alternative methods. Would capitalizing a new biotech fund be such a method? Best wishes.
flipper44,
One thing this trial has an advantage over almost any other I have ever followed closely is (some) very mature data (PFS and OS) for regulators to compare to more recent data trends and criteria differences. Earlier enrollment period patients vs later enrolled patients. The earlier patients include the small vanguard group from very early on. So essentially 2008-2011, 2012- Fall 2014 and late 2014-October 2015. I would love to see how these time line charts stack. Best wishes.
iclight,
Are you saying that Fraunhofer's reputation is for sale to any bidder no matter the damage they might do to it? Sounds to me like you are confusing Fraunhofer with a certain chemo pumper from MD Anderson. Best wishes.
iclight,
Please remind Fraunhofer not to be so enthusiastic about optimizing a failed product next time. I am sure after this they will give that warning the fullest consideration it deserves. Best wishes.
biosectinvestor,
The SAB is going to help NWBO make the choices regarding trial design and endpoints for the Phase 2 Direct trials. They will also be helping to choose the most important checkpoint blockade combination(s) for use with their DCs and the points at which any additioal optimization improvements beyond those already mentioned by them might best be encorporated. Any Phase 2 L combo trials would also look to be registrational but would more likely need to be broad enough to allow for some tweaking for safety and efficacy optimization purposes.
After all is said and done with regard to preparation for Phase 2 Direct and the SAB is still all on board, what do you think might happen to the stock price if it was announced that one of the trial endpoints was stable disease at 8 weeks? Best wishes.
AVII77,
I stand corrected. Thank you for your response as I remembered the partial quote but not the context. So how do their comments about the trial nearing completion and the change in primary completion date to just weeks from the update line up? Also, would multiple regulators tolerate a failure to disclose unwelcome findings unless there was a good trial related underlying reason? Thanks and best wishes.
Rkmatters,
Thanks for the clarification. Best wishes.
AVII77,
Based on what flipper44 posted, NWBO might put themselves in legal jeopardy if they don't disclose primary completion and results due to the fact that they already made a statement about turning "good news into bad". The onus is on them to clarify what that good news was and is because they did not clarify before. I don't think they are in a good position to stay silent at this point. This does not mean that FDA directives about confidentiality will not have some influence in the course of legal proceedings if this is needed for clinical trial integrity. Best wishes.
chinatown1980,
I had no conversation with Les. I simply remember there being a kind of mea culpa that came from someone else's reported conversaton at some point. The extrapolation is easy from there with regard to NWBO actions and Mr. Woodford sidelined.
As far as Dr. Linda Liau is concerned, she has simply expressed a desire to move on from her position at UCLA and with her being about 10 years+ younger than Linda Powers, I can imagine a nice transition route for both of them. No need to worry about it being for a while yet since the lawyers will have their hands full for some time as others continue to try to take NWBO down. Best wishes.
afford567,
You did very well here with this post. You took emotions out of the discussion and developed a good line of reasoning. Keep up the good work. Best wishes.
chinatown1980,
If NWBO took a calculated risk with something they did with approval in Germany before FDA gave their full approval of the action and FDA could possibly come back and say that the trial was now not well controlled how would you state the risk?
Primary completion now expected in weeks not months or years. Linda knew how to leverage any potential big pharma influence at FDA. Best wishes.
chinatown1980,
What NWBO did wrong was to trust in funding from Mr. Woodford too much. Les Goldman basically said this without saying it directly when talking about what they should have done in hindsight. Any move to secure financing independently of Mr. Woodford, though, would have caused a stir. Obviously they did not want to give Mr. Woodford too much leverage so an independent financing would have been the only way to go with a large financing as Mr. Woodford never brought on any significant independent and favorable sources of financing that he had mentioned. This brings us to where we are today. If the new investor is not Mr. Woodford and still is willing to do the financing without warrants as Mr. Woodford was, then hopefully we have a long on board who is willing to stay with the plan. If not, Linda Powers has made clear that the key components of the technology will not fall into the hands of others. Dr. Linda Liau's newest quest for an MBA may be part of the longer term plan to take her research and that of others to a new level as she mentioned a "glass ceiling" at UCLA. I can think of a place or 2 where her talents and patents might fit in perfectly in a few years and where the glass ceiling was already broken. Best wishes.
flipper44,
Those who might see what is happening either don't trust their understanding or are being held out by the low current price. Many others just don't see what the signs are pointing to. The easier read is the September turnaround and the price holding today. The obvious reason is that delayed eventing results are providing underlying support but the $5 crowd is being held out. Best wishes.
learningcurve2020,
Do you mean CEOs like Dr. Prins who aren't really CEOs or do you mean CEOs that talk about partnering but won't accept lousy terms like Linda? Best wishes.
maverick_1,
Great post. Maybe someone finally has seen enough to be convinced. Time will tell. Best wishes.
kabunushi,
I agree with you and I think steps are being taken behind the scenes for this to happen while at the same time keeping critical components under private lock and key until everything crazy plays out. I also think that the Germans have enough invested in the success of this technology that they will intervene if necessary. Just a hunch. Best wishes.
2014turnaround,
Thanks. I'll take the science and good (God's) luck any day. Best wishes.
2014turnaround,
You are correct about when a stock trades above the offering price after a financing deal. In this case it has to do with market makers and investors deciding the odds for some type of nearer term positive news is better than even. The stock may move lower initially Monday if some investors missed the financing news but I do expect a rebound afterwards. Traders like the 2 day test of the waters especially when looking for a double bottom . Best wishes.
chinatown1980,
The other reason might be to clean up their books for a partnership and or financing deal.
As far as Adam is concerned you are right. I need to tweak my theory because I expected more specific news about Direct might be released. I believe NWBO chose to hold onto that news until they get some further patenting considerations taken care of. The hints are there though. Best wishes.
Do Due Dilligence,
I agree with all your points. Maybe I didn't make this clear enough by the way I wrote my response because I did take into account whatever negatives that the bear thesis thought had some merit and (might) hold some weight. Best wishes.
md1225,
Thanks. Now let's get some of our buddies to lock up these shares and drop daily volume to under 200,000 shares before news. Best wishes.
exwannabe,
If optimization was occurring during the Phase 3 trial and this negated FDA approval and the Germans approved it for HE anyway because their optimization made it work even better, what kind of pressure do you think that would put on FDA? I am not saying this is the case but as far as I read equivalency, proof that a product is as good as or better than what was in the original treatment is all that matters. There may be some wiggle room too if cell selection within what is already being produced is all that is changed right? It's technically not a new product because it was already being produced. Best wishes.
hopefulsurgonc,
They were in on the original Nobel Prize for dendritic cell research. They have good reason to want to be out front now. By the way, the more I think about it I think Rkmatters mentioned 88 German site patients. Still going on memory though, as I recall her stating that the SOC patients would represent a little under 30% of total in the trial. Exciting times. Best wishes.
hopefulsurgonc,
I don't have that right in front of me but I believe Rkmatters had said about 84 starting around October 2014 and ending October 2015. The company mentioned heavy enrollment due to large German hospitals in either March/April or April/May 2015 based solely on recall. Best wishes.
chinatown1980,
Or maybe this financing is to clean up the books for some other reason. Best wishes.
md1225,
I think the Germans in general developed a really good understanding of lymphopenia which is a reduced level of white blood cells. Selective lymphopenia is known to be very beneficial. Reduction of T regulator cells and certain macrophages helps prevent a weakening of immune response caused by PD-1 (receptor) and PDL-1 (programmed death ligand-1) intervention. If the Germans knew and had proven there is improved targeting and response by the manufacturing process upgrades, even with lower total lymphocyte counts, then NWBO would have the chance to prove this to the other regulators. SOC would not benefit from this because no immune response is created but treatment would. This would tend to speed up the trial because of more rapid SOC events but just how well treatment would benefit would need to be determined. October turned into November which might not mean anything or it might mean treatment is receiving more benefit than originally projected. I like the fact that NWBO added the analysis at the end to determine how everything with regard to the lymphocyte counts shakes out. I think Fraunhofer convinced them to do this. Best wishes.
iclight,
Let's see, Mr. Woodford began funding with share purchases and eventually a loan to NWBO starting in 2014. According to most bears that should have been enough money to do almost anything including working out a deal with Fraunhofer and others for optimization of process and perhaps product. The development stage began at least a year or so earlier. Now as to whether Fraunhofer has more to gain by pressing for payment or getting the trial to completion, I will let German pride in their "optimization" abilities, expanded access, lowered inclusion criteria and extra month added to primary completion speak for itself. Best wishes.
RuleofK,
I hope Rkmatters doesn't mind me responding but I think she meant primary endpoint data would be a safer bet if the projected completion date was more into next year. She had hoped the trial would stretch out until then as she thinks SOC PFS will be higher than some have expected which puts her expectations for the trial regarding PFS into the nervous zone. She is being conservative and honest about her opinion and I appreciate that. Best wishes.
CaptainOblivious,
Great observation. Best wishes.
Rkmatters,
:) !!!
iclight,
Now why would Fraunhofer need expanded dedicated room for all that new highly complex eqipment? Gee, maybe HE demand has been picking up or anticipated demand from commercialization needs to be met. Why no news about HE? Maybe price negotiations were not finished yet because final PFS median had to be determined from the German trial patients and or the company is going straight to approval. I do think HE patients could have been enrolled but final pricing would need to be agreed to before any revenue is recognized so nothing stated or funds received until that process is finalized. I enjoy thinking about all those lovely possibilities while still fully aware that nothing is a given. Best wishes.
doingmybest,
I like all the points that you have made with regard to staying just with process improvements only but when I read what flipper44 pulled up about Fraunhofer, I became convinced that all the parameters that you suggest would be important for product improvement were already in place at that prestigious institution. They already have the expertise and German regulator recognized process to improve cellular selection so as far as Germany was concerned it would have been a done deal early. As others have pointed out, the Germans were the ones that approved the lowered cell count parameters into the trial. Fraunhofer's expertise surely is the reason why this was done and now one year after the last patient that is currently in the trial was enrolled we receive notice that primary completion has been moved to November from September. Sounds to me like the median from the Germans has been reached and validated which is why there will be no more screening of patients necessary for this trial. This may not be the case and you have very good reasons for staying focused on process but my mind always seeks out the possibilities and I still believe that this is one of them the way the pieces seem to fit. Best wishes.
md1225,
The Germans lowering total lymphocyte count for entering the trial coupled with a slightly delayed finish line and Frauhofer's optimization claim points to something bad for the shorts. Their only hope is that control of the company has a chance to change hands which is why Linda laid out the contingency. Best wishes.
chinatown1980,
Not there yet. It's a contingency not hoped for. Much easier and faster to take it right through the straights. Hopefully the feds and investigators do their job timely. Best wishes.
Turtle65,
The lowering of the trial inclusion criteria by the Germans was perhaps the best clue any of us could possibly get. Many do not understand this. Best wishes.
Turtle65,
Kind of depends on how the market reacts right? Small financings have been receiving applause lately but as I have stated, market makers usually like that double bottom and this provides the opportunity for that.
The recent SEC report mentioned by Adam put strengthened contingencies in place for any hostile takeover attempt. This is in case good news is met with a successful attempt to keep share price low enough that managment is forced to cash in too many of their chips which they do have the option to do now that MFN is off the table. Best wishes.
Adam_Feuerstein,
More like NWBO is under attack by pirates and Linda has an updated contingency plan as, I am sure does, UCLA. If pirates board an empty ship they will have failed. If they board a ship full of Feds they will fair much worse. Best wishes.
kabunushi,
GTR=gross total resection or 100% surgical removal, or no residual tumor mass as measured by current methods. Current methods are better than older methods and the more tumor and residual cancer cells removed, the better the outcome generally expected is. Best wishes.
biosectinvestor,
I was going to stay out of this conversation because a spokesperson for Mr.Woodford and his funds already said why Mr. Woodford is not buying or selling now. Mr. Woodford came to gain access to information that is at least questionable to trade on until it becomes public. My speculation is that because they did not sign an NDA and are not restricted as insiders that this information did not come directly from confidential company disclosures. Instead, a more likely source is Katherine Wolf from Ondra who had notes that had to be returned. Ondra was hired by Mr. Woodford and essentially forced on NWBO as a contingency for his funding. Ms. Wolf may have shared those notes with Mr. Woodford and this is keeping him from being able to trade the stock. Mr. Woodford's spokesperson has not revealed or discounted any potential source of the information referred to. If Ondra was not the source of this information and all information was gained through unrestricted research activity, they could say so directly and clearly. NWBO has appeared to have doubts about Mr. Woodford's intentions. We see this based on the type of financings they have reverted to. One can argue that this is Mr. Woodford's choice but hanging onto shares from their high down into the pennies without selling or buying more to cost average seems very counterintuitive to his fudiciary duties especially since he said he hired his own investigators to look into the NWBO situation. If on the other hand NWBO is not making public some type of information that would otherwise uncuff him then this would probably mean all investors would be kept in the dark longer than they should have been. Best wishes.
flipper44,
The counter balance to this discussion about PFS for SOC with "intent for gross total resection" is that greater tumor burden in those in the treatment arm is correlated to reduced benefit from treatment. This conclusion is based on the suggested lower tumor burden threshold limit Dr. Linda Liau mentioned with regard to normalized immune system monitoring capabilities.
Since this trial is seeking the middle group of total patient population responders we know that the percentage of mesenchymal and proneural patients represented will be at reduced levels due to their typical relationship to the outliers in PFS as well as OS. This will still leave a good percentage of mesenchymal and perhaps a subgroup of proneural along with the other subtypes well represented which, upon crossover, would be expected to be at a higher percentage of mesenchymal phenotype than the unrestricted general population. This would probably result in better overall outcomes for all patients in this trial with regard to OS which is what Dr. Linda Liau implied was indeed happening. The question then remains as to whether or not this middle group can still respond better than the typical patient population with regard to PFS. I believe the answer is yes because the trial attempts to skew towards gross total resection. This will favor SOC to some limited extent but should show the stronger correlation towards the treatment arm as the average patient is skewed toward the point that Dr. Linda Liau believes is critical for DC treatment alone. The log benefit curve comes into play twice as much in the treatment arm as you approach the critical tumor cell count point.
A separate point that came to mind today was that Fraunhofer and NWBO agreed to lower patient standards with regard to cell count probably because they wanted to close the manufacturing system more and incorporate TFF or TFF+ improved cell selection techniques developed by Fraunfofer. Since this was being built in late to the trial, all regulators had to be brought on board and the screening hold had to allow for recovery of patient base if some were not accepted after having been enrolled. Did NWBO take a calculated risk along with the Germans? Maybe. What could be the possible benefit? Well maybe speeding up the trial was what they envisioned. With lower total lymphocyte count patients included, PFS events would probably speed up. On the other hand, TFF and potentially improved cell selection could have optimized the product for those who are treated. These patients might have a slower initial response but an optimized secondary buildup. The reason for this is there are fewer cells to recruit as Tregs. The separation between treated and SOC could, therefore, potentially widen which going from October to November for primary completion could be taking into account. Best wishes.