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Could be, but do they really care?
Maverick:
Thanks for the reply. I respectfully disagree.
Firstly, I was responding to a post averring that legal action as well as a tsunami of disaffection from patients and the medical community would arise in the wake of a non-approval by the FDA. My response was essentially two-fold, to wit: the FDA can get around this by issuing a CRL rather than a non-approval decision which essentially accomplishes the same result for all practical purposes and breaking silence after a non-approval is then too late and much of the damage is already done and difficult to recoup.
As I said, I was a regulatory attorney representing clients in administrative hearings. From what I know, CRLs are devices whereby regulatory agencies can avoid making final decisions and indefinitely drag out the regulatory process by asking "clarifying" questions. This device can be abused by agencies in protecting the interests of, shall we say, "influential" constituencies.
BP could have a lot to lose if DC VAX L is approved. To say that BP is "influential" is being euphemistic. The FDA is a highly political government agency and will be biased towards those constituencies that butter their bread.
It is difficult to argue that a regulatory agency has abused its discretion by issuing a CRL rather than an approval/rejection. The CRL is essentially a questionnaire and responses by the affected party can generate yet more questions thus indefinitely delaying any final regulatory decision. That is why, especially for a small company with limited resources, the CRL for all practical purposes is tantamount to a non-approval. Hence there is very little risk to the regulatory agency in issuing a CRL.
I would hope that LP/NWBO management would make a decision regarding their silence strategy among themselves and their consultants/advisors as opposed to acting upon the advice of an MB denizen such as yourself. No offence but I find your assertion that your advice was taken to heart by LP who then executed upon it to be ludicrous. And after she supposedly had taken your advice, what did you do---sell your shares?
Under LP's silent strategy, the share price has lost 98% of its value. Good management stewardship? I think not. And don't blame it all upon the nefarious naked short forces which in every telephone conversation I have ever had with LG he complained about this ad nauseum as THE major reason for the share performance. Pretty much the same as saying the dog ate my homework.
Anyway, different pokes for different blokes.
GGB:
I thought about it again and yeah, I still think so.
GGB:
Think again about what?
Iwasadiver:
Thank you. Looking forward to your shedding some light. Always glad to hear from a professional.
Best regards,
U
Yeah, so what?
Not if the FDA decides, instead of approval or outright rejection, to issue a complete response letter. Hard to argue that the FDA abused its discretion by issuing such a letter if it can raise legitimate questions. And that is not difficult to do. The FDA has wide latitude and even though a CRL will delay things indefinitely, the FDA has a right and even a duty to do so if it has questions/concerns.
NWBO's silent strategy could backfire and embolden the FDA to do so. NWBO is rather unknown and has little leverage. Did Beau Biden, John McCain or Susan Bayh(who was on the NWBO BOD) avail themselves of DC VAX L? IMO, not likely.
Why NWBO cannot even defend itself against a poly-sci major who has done a great job creating FUD and battering the share price. This is not lost on the FDA. Anyway, the FDA is a political animal and has its bread buttered by much more powerful and influential interests than NWBO.
How does NWBO deal with this? Silence is definitely not the answer. Stellar results and/or a partnership/BO. At this point, I think many shareholders would be happy with a buck or two BO and call it a day. Going it alone is a long, uncertain and highly risky road. JMHO.
Doc Logic:
Raising hell by patient advocates, friendly oncologists and the general public after a CRL or no-approval decision by the FDA is too late.
NWBO's strategy of silence for fear of upsetting the FDA and possibly compromising a chance for approval all the while allowing the free fall of the share price is completely misplaced. Malevolents like AF have had a field day running rings around two lawyers who should know, and assumedly can do, better. Blaming the share price cratering on naked shorts has worn thin especially after statements from LG that a string of PRs would also include announcing action against such malevolents. Rings hollow and sounds very much like "the dog ate my home work for lunch." When nothing happened and asked WTF is CB doing, LG sheepishly averred that it is not the "right time." NWBO management has not met a timeline they did not miss---and by miles.
I have been a regulatory lawyer and worked with regulatory agencies in the US. These agencies have their own agendas. They will not be "nice" to those whom they regulate, even if they are "nice" and keep silent. It is a sign of weakness especially from a small company. The agency strongly believes it has leverage and the meek regulated party will do nothing and roll-over. I have seen this time and again. Agencies don't want trouble especially from a squeaky wheel. NWBO is a relatively unknown factor because it has been so quiet. It is hardly mentioned in the literature and when it rarely is, the information is either dated or even wrong. The FDA may believe that even if it releases a CRL pending ultimate approval that there will be relatively little or no push back. "Who the hell is NWBO"?
The time to break silence is now and not after a decision by the FDA. IMHO, the strategy of silence has proven to be deadly, not golden.
You are correct wrt the CRL. It will not issue as a result of top line. The FDA will review an application and issue a decision which may be--approved, partially approved, rejected or a complete response letter.
Meirluc:
I am sure that the medical and RA communities will understand. My concern is the investment community and its perception of "mixed" results. Long tail success may be counterbalanced by failure to meet the primary/secondary endpoints. Thus, share price may not move the needle. We have already seen this with the JTM. It reported rather good results but the share price needle was not sustainably moved. This was due to the facts that the results were blinded, were measured against historical norms from surgery and not randomisation and the primary end point, PFS, was not addressed on a blended basis. So you could say that the JTM results were "mixed" thus not moving the share price needle.
Same could easily happen with top line and the market's reaction thereto. Not only do results need to be stellar wrt to long tail but they need to be presented in such a way as to ignite the investment community's interest.
If not, fund raising at unattractive share price levels will drive the share price down. Mixed results as perceived by the market will not virtually guarantee FDA approvals expeditiously or otherwise. While there might ultimately be RA approvals including the FDA, the road to these approvals may be protracted and painful for long suffering investors---unless you are one of those investors in for the very long run and don't really care about interim share price damage. I also fear that absent stellar results, given the FDA's BP leanings, they may decide to issue a CRL. Not an outright rejection but a serious bump in the road with approvals in the more distant future.
I hope you are right though, although i think my fears are well founded. JMHO.
I cannot argue against your response. It is a good one, makes a lot of sense and comes from a committed professional.
You say that you have spoken with oncologists in your network. What do they know about DC VAX L/D? Do they think the PFS end point has been achieved? If not, does it really matter? Even if PFS eventing were not significantly improved over SOC but progression were slowed as a result of the vaccine unfolding its effect over time, wouldn't this be a good result? Do you think the SAP would address this aspect? How about OS separation between Tx and crossover/non-crossover arms? Does it matter? If little separation, isn't that a good thing because it would show some efficacy wrt "late" vaccinations?
On what groups does DC VAX L show efficacy in your/their opinion? Methylated? Methylated what? Pro-neural, MES, classical? Dr. Liau has remarked upon the especial efficacy of DC VAX L wrt to MES. Is that methylated MES or all MES?
Have you seen the chart in the intro to the iHub MB that delineates Methylated and un-Methylated and further breaks down M+ and M- into molecular sub-groups. M+ , according to the chart, is composed JUST of pro-neural. However, in earlier studies, Prins and Liau found that the vaccine has little to no effect on pro-neural. Further, in prior clinical studies, Prins and Liau found that the vaccine is particularly efficacious wrt to mesenchymal(M+). However, in the chart, MES, along with classical and neural, is in the un-Methylated group where DC VAX L efficacy is considerably less than in the M+ group. However, Prins and Liau found that MES responded much better to DC VAX L because it was more "immunogenic".
According to this chart, then, it appears that DC VAX L works very well on pro-neural because it is M+ and may also work very well on MES even though it is in the M- grouping. If this is so, then DC VAX L appears to work rather well on a majority of nGBM. M+(pro-neural according to the chart) comprises almost 45% of the categorised groups(N=293 because 38 initially were not categorised). In addition MES according to the literature comprises between 25%~40+% of all nGBM. M+ and MES would cover over 60% at least of the nGBM population.
Look, IwasDriver, I am no expert and I am open to persuasion. Can you and/or your oncologist colleagues address the foregoing in some depth? I have read some of the scientific literature but not being an expert and not doing this for a living, I get confused. Your thoughts would be greatly appreciated by me and I am certain, by a lot of other MB denizens. BTW, I raised these questions in considerably greater depth with Alton Boynton and never received any response despite extensive follow-up. Ditto with Innes. Ditto with Rago. I also raised these issues with another professional who occasionally posts who could not really respond. Gave an honest answer: "I don't know". Best regards.
Umibe
Meirluc:
What concerns me are the following:
1. The primary and secondary end-points are not going to go away. These will be considered in any assessment of efficacy along with a number of other factors. The lack of discussion on PFS in the JTM is telling. Blended results for PFS were probably too close to call and thus the call for adjudication. if, even with adjudication, the primary end-point is still not met, while not fatal in and of itself wrt reg approvals, it is still a strike. A miss here is not of such "prime" importance to the RAs and medical communities, but it will be to the market/investment community.
2.Failure to achieve the primary end-point will be trumpeted as a failure in the trial and investment naysayers will focus on that failure despite countervailing positive news. The market will see failure to achieve both the primary and secondary end-points as overall mixed results. This will taint otherwise positive longevity, etc. data and reg approval will not be considered by the market as undeniable. It won't be a slam dunk and approval, assuming it will issue, will not be expeditious at least by market standards. I believe that ultimately DC VAX will be approved but there will be extensive share price damage along the way. There will be toxic financing along the longer road to approval as perceived by the market place.
The share price seems not likely to rise very much, if at all, if results are mixed.
3. Top line is of critical importance particularly in how it is presented. So far, whatever has been revealed by NWBO has not been clear and unambiguous. Many more questions rather than answers have been engendered. And the strategic silence because of NWBO's fear of compromising or otherwise being seen as putting "pressure" on the FDA will further pressure the share price if top line is not greeted by enthusiasm by the investment community. This has been NWBO's history thus far. Hopefully, DI will be instrumental in guiding the top line presentation process so that in addition to appealing to the medical and regulatory communities, it also appeals to the investment community. This is, presumably, where DI's value lies.
4. NWBO's strategy of silence is not working. It has created FUD. Laying blame on malevolent market forces has worn thin. Failure to meet even one timeline by management has destroyed market credibility. It is a waste of time to even talk to management because anything they say is not to be believed. Innes is no improvement on LG. IR is not the better for his hiring. I don't blame Innes for accepting an offer of employment by NWBO. Presumably he is now in a better place than he was with Oppy. However, he has no experience in IR and was in a backwater brokerage satellite office. Does not inspire a lot of confidence. He appears to have been hired as an expensive convenience to LG who still calls all the IR shots. Thus, I fear that NWBO management will flub the top-line presentation which is of critical importance, especially for the investment community. So far, NWBO management has a poor track record. Will it change for the better with top line? Stay tuned.
That is the problem. I think they will mangle the process and top line will not be presented persuasively. More questions than answers will result, silence will then ensue in order to "safeguard" the regulatory process by not upsetting the regulators in any possible way. Uncertainty is reinforced and the share price savaged through repeated toxic financings. The FDA has its own agenda regardless of how silent and protective of the FDA NWBO is. I would not be surprised if the FDA "nicely" issued a CRL---a kiss of death while not an outright rejection.
Silence is not golden; it's deadly. JMHO.
Believe what you like. Odds are that primary/secondary were missed. Revision of SAP to telephone directory proportions seems to lead to that conclusion. Top line results will not be undeniable. Probably raise more questions than answers. Adds to uncertainty and whether approval anytime soon. Highly toxic financing looming and R/S not too far off. The market knows something. New lows coming soon. JMHO
Have you looked at the pps lately? It is down about 40% from ASCO. If the data you expect is so good, why has the share price been cut almost in half? It makes no sense unless the data is questionable and ambiguous.
The market players almost assuredly know what is going on. It is almost a certain bet that the primary and secondary endpoints have been missed. The mOS of 23.1 months just does not yield enough of a cushion and that is measured from surgery! Avoiding talking about PFS most probably means that that endpoint was missed and that they are trying to save it with adjudication. If even with adjudication the PFS endpoint is not met, look out below!
No wonder they went with an amended SAP the size of a telephone book as DI told some MB members. Top line is going to be confusing and create more questions than answers. I get the frightening feeling that the top line data will not be clearly undeniable. It won't speak for itself. There will be endless, complex, confusing and questionable analysis trying to spin the data in a positive light long after top line announcement.
I think announcement of top line will be extremely disappointing and with NWBO management's penchant for lack of transparency for fear of upsetting the RAs, revelation of top line will be a nebulous event. Instead of the pps going up, they will hit single digits. RA approvals will be at least a year away, assuming they issue, and the uncertainty of approval plus extremely toxic financing will drive the pps to new lows even after an almost certain disastrous R/S.
NWBO's excessive and unfounded fear of the FDA has impelled management to follow a disastrous strategy of silence and parsimonious revelation when they do say something that engenders obfuscation and encourages a complete lack of credibility.
I am afraid that top line revelation won't happen this year. Maybe that's a good thing. Next stop, mid-teens just as I predicted many months ago. You can thank NWBO management. Disgusting. JMHO
I doubt that IR would provide that information to you. It is material information and I can guarantee that LG has instructed Innes not to say anything about the timing of the SAP.
Earlier, a poster wrote that Innes bet him a steak dinner that top line would be released during the month of September. I doubt Innes said any such thing. If he did, he was expressing a personal opinion except that as a company IR executive he cannot express a personal opinion because it can be easily confused with a company blatant hint since Innes is an official of NWBO. Assuming that Innes was stupid enough to have said such a thing, and LG found out about it, LG would have come down hard on him making it even less likely that Innes subsequently talked to you about SAP timing.
I hope you are right on Sawston but my gut says no. Further dilution is more likely. JMHO.
A significant premium over current share prices in all scenarios except top-line sucking? And what premium(s) is that?
First, I think that NWBO would like to hold onto the Sawston property and it will continue to do little raises, as may be needed, up to top line announcement which should occur later this year. After all, Innes has said that they can raise funds at any time. If top line is not announced within this year, we are in for some trouble. By now, LP, et al, have a pretty good idea where they are with the trial and whether they have met the primary/secondary/tertiary/etc. endpoints. They know what data they need to present in accordance with the SAP they have developed and which will hopefully be acceptable to the FDA and other RAs. They may require another small raise to carry them through to top line assuming it is announced this year. Not the end of the world and they would like to keep Sawston at least for another rainy day. JMHO.
Second, if top line sucks, you can forget about a lot of dilution. The pps will be in the low single digits. No one but possibly LP and polly-anna friends may provide funds just to keep the lights on but most investors will call it a day. A lot of them will be disgruntled and I have no doubt that lawsuits will ensue. LP/LG will be busy fending off these challenges and focus will be split. For all practical purposes, NWBO as an investment is over. Approval is way off if it ever ensues. Only die-hard believers will be left to pick up the pieces but for all intents and purposes, the saga is over. Management has had serious credibility issues to put it kindly and with top line data that sucks, the science upon which most investors had been banking on, and certainly not on management, has also lost credibility. That is all she wrote.
I am reasonably confident that top line will not suck. I don't know if it will be stellar enough to propel the share price up to a dollar. However, I think the odds are that top line will be good enough to at least double the share price from current levels. In such a case, perhaps a significant number of longs, disappointed that top line was not a grand slam rocketing the share price, will sell out and move on placing downward pressure, again, on the share price. Hopefully, LP did not lie about "home-runs" and all this silence was worth it. JMHO
An equally pertinent question is why would NWBO management specifically hire Innes in the first place? He was in a backwater satellite Oppy office with a title of Senior Director, not even a VP as far as I can see in his resume. No experience whatsoever in Investor Relations. You would think that NWBO could do a lot better and if not, for the reasons you state in your post which are entirely valid, why hire an IR individual at all? What has changed? Are they more transparent than before? Is the confusion and obfuscation gone? I am certain that Innes is getting a healthy compensation for being an LG cushion. Not a good allocation of scarce monetary resources. Look at it this way. I'll bet that his salary alone is at least 10% of the latest raise.
And if Innes was such a successful broker why leave this practice for NWBO? Now he has all his eggs in one basket--employment and a hefty investment in NWBO according to him. This just does not pass the smell test.
IMHO, Innes is even more confusing than LG. Top-line in September? Innes is definitely gonna lose his steak dinner bet. Question is----will he pay up or follow in LG's footsteps by saying "i never said any such thing". Stay tuned.
Dr. Bala:
I suspect that when this long standing trial was commenced, PFS, as a surrogate for OS, was selected as the primary end-point. From rad/chemo trials it was recognised that PFS was a good correlative surrogate for OS which would serve to shorten the trial. However, considering immunological approaches, PFS as a surrogate for OS may not be a good correlative. The gold standard is still OS. Due to the length of the DC VAX trial, it now has enough OS data so that the PFS surrogate has less significance than it originally had. And as I have mentioned, even though PFS eventing may not significantly surpass that of SOC, it is within the realm of possibility that the vaccine dramatically slows progression rate such that patients live longer with a better QOL. Such a result, if part of the SAP protocol, would nullify any shortfall in meeting the original PFS end-point. This would be well understood by the medical and regulatory communities--at least one would suspect. It may be less well understood by the short-attentioned general investment community which would likely focus on a failure to meet a trial primary end-point. Thus, although strong data is important, its mode of presentation is also important especially for the investment community. This is where Innes who has experience as a market pro will earn his keep. I believe that is why he was hired. It is critical that top line presentation has a significant and sustaining effect upon the share price. JMHO.
Dr. Bala:
Let me try it another way. The authors of the JTM article could have handled PFS much in the same way as OS was dealt with. For example, they could have averred that under SOC mPFS is historically anywhere between 6~9 months. Blended data shows that mPFS is 13.2 months. There are issues concerning confoundment by pseudo-progression and accordingly, in order to confirm accuracy of this metric, an adjudication will be performed at the end of the trial---or words to that effect. The fact that this was not stated suggests, at least to me, that the blended data was not strong at that point and thus the authors chose not to address PFS.
IMHO, I believe it is possible for patients to live longer by engaging in DC VAX therapy even though PFS is not significantly improved over SOC. I have raised the possibility that immunological therapies take longer to manifest their efficacies vis-a-vis chemo/rad approaches as part of SOC. As time unfolds and the therapeutic effects begin to strongly take hold, PFS eventing may indeed have taken place, however, PFS rate of progression has been slowed and in some cases reduced to zero. Thus, there is an increase in the PFS/OS delta whereby patients are living longer.
The results of the trial need to appeal to basically three constituencies: medical community, the regulatory agencies and the investment community. Although PFS is a primary end-point, there may not be statistical significance or the results may be relatively ambiguous. Failure to meet the primary end-point of the trial may not be fatal and other metrics may show results such that regulatory approvals issue despite the failure to achieve this endpoint. Accordingly, insofar as the medical/regulatory communities are concerned, failure to achieve this end-point may be of lesser significance when considering other factors. However, the investment community thinks much more simply and has a short attention span. The more complex and complicated an explanation may be in addressing PFS within the context of the trial results, Wall Street may understand little but the fact that NWBO, at least technically, failed to achieve this primary end-point. Accordingly, the share price may not significantly increase thus engendering investor concerns of continuing and highly dilutive financings up to ultimate regulatory approvals which may not be around the corner.
Accordingly, the manner of presentation of top-line will be of utmost importance. Of course, this will depend upon the data and the mode of presentation will be made easier in accordance with the strength of the results. With NWBO's history of being very parsimonious with its revelations and concerns with possibly upsetting the FDA and other RAs by revealing too much, top-line presentations may be found wanting, at least by the investment community, which will look upon failure to achieve the primary end-point as a total trial failure.
Strong/clear and easy to understand top-line results, including meeting the primary/secondary end-points, with a statement that NWBO will be filing a reg application--a best case scenario-- will undoubtedly go a long way to insure a sustainable significant increase in the share price. JMHO.
I don't think NWBO knows that the trial failed to meet the end-points but I submit that they they have a pretty good idea given the data they already have, and of course, input and advice they obtain from their professional statisticians, the SAB and the principal investigators.
The fact that PFS was ignored in the JTM article is very telling, at least to me. Yes, there is the issue of confoundment with respect to pseudo-progression. However, I think that due to this issue, the blended data on PFS may have been too close to call at best and it was then hoped that adjudication at the conclusion of the trial might help bring PFS over the primary end-point line. If even with adjudication, the PFS primary end-point is not achieved, this may be perceived as a significant negative.
However, IMHO, failure to meet this primary end-point is not necessarily a considerable negative IF NWBO can explain it properly. For example, as I have alluded to a number of times, PFS is a surrogate and perhaps not entirely appropriate in evaluating immunological therapeutic approaches. These therapies take more time to manifest their efficacies than SOC(chem/rad). Accordingly, and I am speculating, there may have been earlier than expected PFS eventing because the therapeutic effects of the vaccine needed more time to take hold, and even though there was earlier eventing, the rate of its' progression was slowed and the delta between PFS eventing and OS was increased thus resulting in patients living longer than expected.
While I think that lack of SS/failure to meet the primary end-point will not necessarily result in failure to gain regulatory approvals or result in rejection by the medical community, I do think that it will still weigh heavily on the share price. No doubt, the bear investment community will trumpet the failure to meet "the" primary end-point thus keeping a lid on any significant rise in the share price and thus engendering fears of continuing toxic financings until less than reasonably certain reg approvals which may not be near term in any event. If there is lack of SS/failure to meet the secondary end-point, this will further compound negative perceptions by the investment community even though other data may be highly favourable and suggestive of efficacy. It depends very much on how top line is presented and, of course, the strength of the data. JMHO.
Sorry, but I do not quite understand your post. LP is alleged to have at least inferred they have a home run. LG has also allegedly said that they will continue to collect data until the results are undeniable. This could easily be interpreted to mean "undeniable for good or bad ".
However, I believe that NWBO needs very strong results especially if it fails to achieve primary/secondary endpoints. These will not go away even with an amended SAP. Home runs in OS milestones and remarkable efficacy in MES, which is the most aggressive cancer with the poorest survival and constitutes a relatively large sub-group, would go a long way to assure approval even though results for M- might be less than remarkable but still show some improved efficacy over SOC. The "home runs" may mitigate failure or unremarkable results in the primary/secondary endpoints leading to approval.
I do not know whether NWBO, in fact and absent unblinding, has any home run. LP does not know for sure either unless somehow she knows what the unblinded results are. I believe that is highly unlikely. However, given her expert statisticians, the SAB, PIs and the data NWBO already has, I believe she has a good indication of how the trial will play out. JMHO.
I think this raise is a bridge to provide extra insurance/time to sell the remaining Sawston property for enough funds to see us through unblinding/ top line without further dilution. If unblinding/top-line were around the corner, this raise would have been un-necessary. This raise seems to be just a bridge to more substantive financing through the sale of remaining Sawston RE.
Thus, I think unblinding/top-line won't happen this year. LP may want to drag out data collection to November, 2019. In any event, the tea leaves seem to indicate that unblinding is not near-term. If that is the case, then I think the odds of the pps tanking to new lows are relatively high. If positive results are announced when the pps are at new lows, such a launch pad may not provide sufficient momentum to even reach a buck per share.
You may call this pessimistic but I rather call it realistic. Depends upon your point of view. They say that beauty is in the eye of the beholder. JMHO.
In any event, the so-called "war chest" created by the Sawston sale was supposed to carry NWBO through to top line and unblinding. It was expected that there would not be any more dilutive raisings at least until then. Like so many timelines they have expressed or alluded to over the years, this was also wrong. NWBO management has an unenviable track record of nearly perfect misses that have not even been close.
And we had to find out about this through a prospectus and not through a courteous PR. My comments on IR still stand. Still a zero and waste of scarce resources. The only change is in the initials but IR is still overseen by LG, make no mistake about that.
As I said, probably NWBO has yet to submit the SAP to the four RAs. The pacing item will be RA reaction to the SAP which may involve time consuming back and forth. I also have a feeling that even with several hundred queries remaining, the data scrub is not yet completed and will also need to be done for continuing data collection until hard data lock. I believe that unblinding/top line will not happen until 2020 and that granular findings and analysis won't take place until ASCO 2020.
I believe that in the interim to unblinding/top line, there will be no substantive updates to support the share price. It will continue to bleed just as I predicted. Shortly before ASCO, we were at $0.34 and now we are below $0.23 barely a month and a half after the ASCO debacle. With continued fears of dilutive raises and silence wrt to unblinding/top line, the share price has nowhere but to go down. The shorts need not expend much energy in driving the pps down, NWBO is doing that very well by itself, thank you.
If this continues, I have little doubt that new lows will be reached. And, unfortunately, from a new low launching pad, the share price won't even reach a dollar even if top line is very positive. While I think long tail/milestones/subgroup results will be positive, there will be an overhang if the primary/secondary endpoints are mixed/unmet even though they should not matter as much as the long-tail, etc. The naysayers will focus on the former which may blunt any upward momentum.
The current raise was a hard hit to the solar plexus. Ouch. JMHO.
The question is when??? I don't know but my gut tells me there is something terribly wrong going on. If unblinding were relatively around the corner, why do a raise now? If prior to this raise they had about $16 million left from the Sawston sale and at a burn rate of about $2 million per month all since the end of March, 2019 that would bring them to December, 2019. Enough funds to see them through if they were to unblind in the September~November 2019 time frame. With this raise, they now have enough funds to last them through the end of the year. Are they using this raise as a "bridge" to a relatively imminent sale of the remaining 17 acres at Sawston? If so, that would be unsettling because it would then seem likely that unblinding is not going to happen any time soon and they are busily trying to raise funds to keep going until they can unblind. I would not be surprised if SNO comes and goes without unblinding and it is shifted off to 2020.
I have a very uneasy feeling that the SAP has not, thus far, been submitted to the 4 RAs. One would think that NWBO would have regularly engaged with the RAs during the SAP process but somehow, unsurprisingly, this may not have happened. I don't think there will be a fast turn around with the RAs. They will likely agree to look at the totality of what NWBO has including the existing endpoint metrics and make a determination thereon. There probably will not be any blessings or assurances from the RAs and the most they will say is "let's see what you got" after idling around for months. I think the odds are very high that unblinding may take place during the first half of 2020 probably in the earl/late spring with an abstract at ASCO 2020. I think the ASM will be another bust as was the last one despite the questions submitted and "promises" no less than by a board member that in the next "three~four months news should come about and the share price concomitantly appreciate for financings and partnerships since NWBO is not there yet" or similar words to that effect.
I have a gut feeling that NWBO is buying time and stringing investors along with their tactical silence. Somehow, the primary and secondary endpoints may be too close to call according to the blinded data that NWBO has and advice from their statisticians and SAB. That is why there is so much emphasis on the long tail and its composition and thus the continuing collection of data despite NWBO's "proceeding to unblinding". They need to assure that the data is undeniable even though they may have failed on the primary/secondary endpoints or lack statistical significance thereon.
What NWBO is likely trying to avoid is a CRL issued by the FDA. This is not a rejection of the results but a questionnaire on the results presented as well as explanations which could be quite complex and very time consuming. And the CRL process does not guarantee subsequent approval and could just as well invite a further trial. Such a CRL outcome would be devastating to NWBO and, of course, the FDA could not be faulted since they did not outright reject. Of course, they would argue that in the public interest they are bound to ask questions and require further trials depending upon the responses. After all this time, the issuance of a CRL would be tantamount to a death sentence for NWBO. This could very well happen if the FDA is under the sway of big Pharma. Results would have to be unambiguous and home runs wrt the regulatory pathways pursued by NWBO. NWBO is betting all on milestones/tail and that there is efficacy to some significant degree across most if not all GBM subtypes. In that case, the FDA being afraid of public/medical backlash and possible approvals by other RAs may ignore BP influences and have little choice but to approve.
If the foregoing is the case, it is almost a certainty that NWBO will continue to "proceed to unblinding" well into 2020 with little to no transparency. Silence will continue to rule. They continue to be silent not because they fear rejection but because of the distinct possibility of a CRL. They know that the data results must be undeniable (and unambiguous--home runs), just as LG said on April 28, 2018. They have to be in order to avoid this fate. However, perhaps NWBO is carrying silence and fear of the FDA too far. Complete silence does not seem to be the answer especially when one looks upon the share price devastation. It is not all due as a consequence of the so-called short interests. A little well considered pressure on the RAs may help to keep them honest. Doing it after a CRL is issued may be too late.
The data and manner of presentation of top line will be critical. They need to cater to essentially three constituencies:
Medical community
Regulatory community
Investment community
Successfully presented top line, plus an announcement that an application will concomitantly be filed with the requisite RAs, will serve to raise the share price so that NWBO will be able to engage in necessary funding on much more reasonable terms, proceed to reg approvals and enter into meaningful partnerships actualising the "promise" of Jerry J, board member, made at the 2019 ASM.
In the interim, going into next year waiting for top line with essentially zero guidance except "stay tuned", the share price will almost undoubtedly be savaged and hit new lows. Even with strong top-line results, I don't see the share price hitting a dollar due its low launch level in such a case.
To me, this last surreptitious raise is highly discouraging. At the least, I thought that the Sawston sale would provide sufficient funds to carry us through to at least unblinding and top-line. Further funding between now and unblinding/top-line seems inevitable with more piecemeal dilution and/or probably the sale of the remaining Sawston property at less than favourable prices.
Finally, I would be remiss if I didn't mention my abject disappointment with IR. With its silence and lack of transparency, DI/IR is un-necessary and spending money on his salary plus options a complete waste of precious resources. DI may have worked for a well-known brokerage but was stationed in a backwater city; he certainly is not a heavy hitter with "Wall Street" type connections. Wrong hire with wrong timing--a completely injudicious move by LP. IR has not changed except for the initials--LG to DI--with extra burden on relatively scarce resources to boot, and for what???
I still do not believe that this is all a scam, but it seems to me that, perhaps inadvertently, NWBO is making it look as though it is. Perceptions may ring louder than the truth.
How discouraging and what a shame. JMHO
July/August 2020 is then just as likely
Marzan:
Assuming your info is from a reliable source on the "inside", that is inside information. I very much doubt that your source is in the "know" and what you have been told is most likely more in the line of prediction.
Posting stuff like this is just as bad as the stories made up by the shorts. It is just not credible and it smacks of "tips" brokers give to their clients in order to persuade them to buy house stock.
I hope your "minions" are not buying based on this "tip". It is highly unlikely that unblinding will take place in July or August 2019. I just hope unblinding takes place before the ASM early next year rather than be told, once again, we are "close" and it will happen "soon. Stay tuned.
That makes a lot of common sense. I agree 100% with this and believe these comparisons will be done.
Love to have you visit. You would be amazed at the beauty of the countryside and our tea farms in the mountains. Breathtaking and makes this business one of the most enjoyable I have ever run. We have wonderful customers especially in the hotel and Ryokan market sector in and around Hakone. Beautiful resort areas and Auberges in the mountains overlooking Lake Ashinoko. Spectacular views of Mt. Fuji as well. Proud to say that we have won prestigious international Awards for our teas both black and green!
Yoroshiku,
Umibe
Firstly, yes, I have sold some of my position the last transaction at $0.32 in the week leading up to ASCO. I have been lightening my position periodically. However, what I do with my holdings is really none of your affair. What matters is whether my opinion resonates with MB members and solicits an exchange of ideas and opinions. That is what a MB is all about. You may not like or agree with the opinion and you are free to respond, or not, as you wish.
Secondly, it is you who have judged my opinion as doom and gloom. That is an emotional characterization. Others may look at the opinion as a distinct possibility or even probability and dub the opinion as being "realistic".
Look Kabu, I think that you are annoyed at my expression of these views and attack me by averting..."well you have not sold a single share have you....? This is a MB board and all opinions should be welcome unless they are highly inappropriate or offensive. Freedom of speech and all that. If these "doom and gloom" opinions annoy you, may I respectfully suggest that you place me on ignore just the same as my friend Marzan has allegedly done although I know he "secretly" reads every post I make.
I think that you well understand that NWBO's lack of transparency for whatever reason has encouraged negative opinions which I humbly believe could have been mitigated with a more enlightened IR/ media communications approach. I think that at least to some extent NWBO's lack of adequate communications has added to the crash in pps from a once high of $12+ dollars. It is highly disingenuous to blame it all on the nefarious and dark pool forces. The fi-ASCO at ASCO was plain and simple, at least to me, as another missed opportunity in a pattern of such events which further undermined credibility in the management team and exposes shareholders to further and possibly significant erosion of value.
If you don't like reading this, just don't.
Still friends? LOL
Kam:
A BO is just wishful thinking. It is 99.99999999% certain not to occur after top line and before approval, if it comes depending upon results. Obviously, the unexpected occurs commonly in trials such as NWBO's. No BP is going to buy a pig in the Polk for an outsized price. Jest ain't a gonna happen.
Assuming approval around mid-late 2021, there may be some rumbling about an acquisition but in my view it just won't happen. Big P will low ball offers and LP will not sell at that price. No Goldilocks zone. Likely that NWBO slogs it alone for an indeterminate period. With demonstrated success and profitability there may be a BO but that is not in the near to intermediate future. Thus odds of a BO anytime soon are extremely low. JMHO.
I own a tea company. We are in major hotels or better yet come to our factory store in the inaka( country side).
:)
No, he was a Brit.
Marzan (and his Minions) and Chris LaCoursierre?
Sorry but I could not resist. LOL.
PS: actually LF you are def not clueless. Good insights though I may not always agree. Keep your posts coming. I find that they are very helpful and I am sure many on the MB think the same :)
Edit: not around the corner
IMHO it is likely. The SAP is not complete yet. No timeline for completion and submission. The SAP is composed of several hundred pages and as DI confided it is as big as a telephone directory. It is very complex with state of the art statistical tools. There is no doubt in my mind that blessing turn around by all 4 RAs is around the corner. I hope all 4 RA approvals can be obtained by SNO but it is probably safer to say end of 2019/early 2020. An abstract will be prepared for ASCO 2020 with detailed analysis. This is a year away.
There is nothing for NWBO management to say other than to invoke diversionary tactics as it did at this ASCO wrt D. FUD is a natural outcome and the nefarious forces will be out to drive down the share price. NWBO will likely need more funds and the last of Sawston goes. They may need further financing in addition to Sawston sale and depending upon news it may not be highly toxic although it may be highly dilutive.
To me and a number of investors in the network, management has no credibility and we shareholders are flying blind through all the turbulence. I think this likely scenario breeds an environment of much lower share prices. Eventually and ultimately, I think they will succeed. Will results be blockbuster? Stay tuned. The share price goes much lower before it recovers. As a very long term investment, it might be ultimately worth the wait but it depends how old you are. All bets are off if we get a pleasant surprise and RA blessings say in September as DI may predict. Top line might come reasonably shortly thereafter. But in my view, that is a long shot.
To those that think LP is hearing up for a sale, I hardly share that view. If it has any glimmer of a possibility, it will be after reg approvals which I think are relatively long off. I think the odds of a sale are extremely low as LP will not be asking in BP's Goldilocks zone. It will be a long long slog to the "Promised Land". JMHO.
Kabu:
I would love to be more positive/less pessimistic but somehow despite encouraging indications NWBO inevitable creates a dark cloud surrounding it. ASCO, again, was a disappointment. NWBO management has only served to reinforce the notion that much of what they say(or don't say) is virtually meaningless and lacking in credibility.
Anyway, in this you are certainly correct. My posts do not reach management and they have about as much influence on their conduct with retail investors as has DI thus far.
JMHO
Among other places, I own a condominium in Tokyo which is located in one of the 23 wards of this sprawling city. Umibe is literally reclaimed land and it can be named Ocean Beach Place. This where my condo is located bordering a park and tributary river winding its way to Tokyo Bay.
Umi is translated as Ocean. The ward I live in is Koto-ku and I am about a 10 minute subway ride to the Ginza and Nihombashi where I have one of my offices.