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
