The drop to $0.14 is concerning because I have a gut feeling that another financing deal is in the making. They need money and I believe that another financing will take place between now and the "interesting" ASM, if it takes place. Insofar as the ASM is concerned, if it takes place and as scheduled, it will almost certainly be virtual. I have heard that it would be one-way with no questions from the virtual attendees.
I have just a gut feeling that another financing is around the corner barely a month after the last one. It will be very difficult to attract investors now unless either a highly toxic deal is structured or NWBO management lets the cat out of the bag and is up front with investors as to what is so "interesting." It seems to me that NWBO is between a rock and a hard place and going out to investors for another raise so soon after the last one, if my timing is right, is extremely concerning both in terms of fiscal (mis)management and what this communicates to the market. I would not be surprised to see the SP dip to single digits. I don't believe I am alone in this feeling as even Doc Logic prognosticated, albeit some time ago, that the SP could dip to $0.05. The need for financing and especially the clandestine silence/teasing "interesting" tid-bit have given impetus to SP destruction. Everyone knows that NWBO management has blown every guideline they have given out. LG has repeatedly talked about a string of PRs bolstered by a board director at last year's ASM claiming that PRs in 3~4 months would help to bring the SP up. Can management be trusted? Good managers do what they say they will do. Sometimes unforeseen circumstances interfere. In NWBO management's case, they have 100% blown every thing they have ever said. Is "interesting" just another shuck n' jive?
OTOH, I do believe that the trial will be successful. But the question is---how successful? Les and DI have both said that the FDA proposed guidelines which they appear to be following in practice is "huge" for NWBO in terms of ultimate approval. It means that historical sets can be used as comparators in analysis, in addition to sui generis trial comparators. This appears to be a mixed blessing at least insofar as market perception is concerned. The implication is that IF the trial's end-points can relatively comfortably be achieved, what is all the fuss about? The long tail, which we all believe is long and robust is icing on the cake. Surely, by now, NWBO has some degree of confidence as to the degree of success in meeting all these criteria. They have all their professional statisticians, the SAB, the PIs like Drs. Liau and Ashkans and reams of data which we, as investors do not have. However, in light of possible confoundment caused by pseudo-progression(adjudication should clear this up, I would think at least to some significant extent) and cross-over(not enough and SS separation), there is an obvious concern that these primary and secondary endpoints may somehow not been met or the results not considered to be undeniable. The original SAP was expanded upon to incorporate new developments/information as the trial progressed over many years. This, of course IMO, hints that perhaps the original end-points were considered to be in jeopardy of achievement and hence other evaluative criteria, more in tune with immunological therapies, needed to be incorporated into the SAP. The compilation of this SAP was a "ginormous" task and required review/agreement with the relevant RAs---or at least NWBO thought so. Much time and effort was spent on this task. So it seems reasonable to assume that there were issues wrt to the initial endpoints such that a more "up to date" SAP was required. I don't claim that the endpoints had failed to be achieved only that NWBO's analysis of the overall blended data may have suggested a close call and that it would be accordingly prudent to modify/expand the SAP. Hence, LP's statement that investors should be focusing upon the long tail results of the trial. That is its length, OS mile-stone achievements as well as its robustness.
NWBO would certainly require stellar results in the long tail in order to de-emphasize any ambiguities or failures wrt to the original endpoints. For example, a stellar result at OS60 could be 25% overall survival covering M+ and MES( methylated and un-methylated?) which comprise close to 50%(?) of the spectrum with a smattering of other sub-groups. Especial efficacy in MES(just M+ and also M-?) would be stellar as this is the most aggressive and short lived grouping as well as a significant percentage category. The question is whether, in fact, the results will be that stellar. I say this, not in terms of whether approval will issue, but rather what market perception will be and the impact upon the SP. If not so stellar then we might just see a very modest SP recovery but with relative doldrums and drifting until RA approvals issue sometime during 2021 or God forbid even as far out as 2022. Stellar/undeniable results would also give urgent impetus to expeditious RA approvals. I would think that the main approval driver would be the FDA, although UK approvals would have some effect albeit not as significant as would be an FDA approval. Less than stellar/undeniable results could lengthen the time of approval and keep the SP in the doldrums.
In any event, we don't have any specific information on the tail and the robustness of its composition. We do have some historical perspectives from the JTM/SNO where in the M- case(55%+), historical SOC/OS was 12.7 months whereas blended OS was 19.8 months--a delta of 7 months from surgery. In the case of M+(its' composition in terms of molecular groupings has not been entirely clarified and which comprises about 44% of the categorised groups--38 initial patients were not so characterised), SOC/OS was 21.7 months and blended OS 35.1 months, a delta of almost 14 months--as per updated SNO from time of surgery. My math skills fail me in reconciling an overall 23.1mOS with the forgoing figures, however, this translates to 20.1 months from randomisation compared to 15-17 months SOC. This is a rather limited cushion that suggests that the mOS overall figure demonstrates significant efficacy for some groupings,i.e., M+/MES and little to no efficacy for other groupings. To some extent this conclusion flies in the face of statements made by Drs. Liau and Ashkans that all patients seem to be living longer and that the vaccine should be made available to all patients as it works to a greater or lesser extent on all nGBM.
The bottom line is we just don't know the extent of success, although I believe that we will have enough for eventual approval. So the extent of success and the length of interim time to approval are great unknowns weighing heavy upon the SP further burdened by the urgent need of financing coupled with silence/teasing carrot dangling in terms of an "interesting" ASM which now may be virtual without the ability to ask questions. Although there may be a broad spectrum as to what NWBO management thinks may be interesting, the elephant in the room is TLD. That is the ball-game. Anything else that may be deemed interesting by management has to pale in comparison. Unless there is something definitive addressed wrt TLD at the ASM and in preceding filings/PRs, management will surely lose any shred of credibility and needed financings will be hugely toxic. LG has said that they can get money when they need it and that is a true statement, at least for now. What he has not said is the source of funds. Vultures can well come in on highly toxic terms which are calculatedly profitable to them. However, how easy is it to get financing from friendlies on less toxic terms who now don't believe management stories anymore. How much more difficult will it be if "interesting" turns out, in essence, to be nothing more than a stay tuned as in years past?
Accordingly, FWIW, COVID and current economic environment call for expeditious and decisive action. The SP is in free fall. There is nothing propping it up. Is management content to let it drop to, say, $0.05 and then with TLD announcement, expect it to rise 6~10 fold? I don't think such multiples would apply, at least in the shorter term. Anyway, that would translate into $0.30~$0.50 which is not very satisfactory. Even a $0.14 base with a 6 fold increase would be relatively acceptable. To stand by and let the SP fall to single digits, an unsatisfactory launching platform on good TLD, is inexplicable and inexcusable particularly when ASM expectations have been stoked and further financing certainly looms in the short term.
If NWBO has something really "interesting"--think TLD elephant in the room--then come out with it NOW. No need to wait until April 18 when the SP is completely in the toilet. I am sure that any investor they tap for an upcoming financing is sure to require assurances wrt to TLD/announcement as that is the top and almost exclusive topic of "interest."
So, yes, Senti, I am very concerned about the SP and its precipitous drop and I think much more, if NWBO does not break its silence soon and especially if there is another financing looming around the corner. The time to come out with what is "interesting" is NOW. Let's hope it is really interesting rather than yet another diversion and carrot dangling ploy. JMHO.
