Meirluc:
Thanks for your response. Many MB denizens believe that we are closer to the end of the trial and top line announcement. I believe that is a fair statement. From last year's perspective, indeed, we are a year closer. However we are always closer, but sh*t happens, like the partial hold for example, which was not within NWBO's control and the goal line has been moved forward. Here we are, with the necessity of filing SAPs with 4 RAs and most likely requiring approvals from all 4 before moving on with the process. IMHO, I don't think these SAPs will be rubber stamped and even though hopefully NWBO management has been working closely with them, I believe there will be some back and forth. Further, we don't know to what extent these SAPs have been developed and when they will be submitted. My view is that this will take time and it is, at least to me, a more reasonable speculation that top line will not be announced at ASCO and more probably sometime in the fall of 2019. However, knowing NWBO's history, I would not be surprised if top line announcement instead comes in 2020. This, too, is not an unreasonable speculation as an integral part of the process is out of NWBO's control.
I have never faulted NWBO for continuing the trial. They did so upon the advice of their SAB and other professional advisors, all of whom have much more information upon which to base their decisions. I believe this was the correct decision and I do not question it. And.......as I have said many times, I believe that NWBO will ultimately receive approvals from all 4 RAs regardless of whether the primary/secondary endpoints have been met. I have my doubts that they will be achieved but for RA approval purposes, I think we can put these concerns aside.
My concerns were based upon share price appreciation when top line is announced. Share price appreciation and sustainability depend upon how good the results are---as perceived by the market place---and when they are announced.
I have speculated that if results are stellar and are announced in the relative near term, i.e., ASCO 2019, the share price should appreciate considerably from present levels by at least a factor of 5x~6x. That could put us in the $1.50~$2.00 range and I think the price could hold at those levels until approval. In fact, share price could appreciate even more if stellar results are announced coupled with a statement that NWBO is immediately filing an application for approval. The share price, quite likely, may not appreciate as much as it might were NWBO on a major exchange, but never the less it would appreciate handsomely from present levels. In this case, I don't think the manipulators could overwhelm share price appreciation although they might place a drag upon it. Without institutional buying, I don't think retail support is strong enough for rocket like ascent in the pps.
If results are not stellar and/or top line announcement is inordinately delayed, all bets are off. Even in the case of stellar results, the share price will undoubtedly be at much lower levels than now and even with the same multiples, the share price may not breach the dollar level.
So there is a difference, in my mind, in what is needed for RA approvals and sustained price appreciation upon top line announcement. The bar is indeed higher for price appreciation IMHO.
I am certain that NWBO management understands the foregoing very well. It is obvious and they are pulling out all the stops to achieve stellar results as best they can. Even though the SAP approval process is largely out of their control, NWBO cannot wait too long to announce top line. They may be between a rock and a hard place in this regard. However, I would think stellar results(strong long tail affecting about 60% of the ITT or M+/MES and good milestones, cell memory indications, etc. could possibly counteract failure in the primary/secondary endpoints) top line announcement is pointing toward ASCO. That is the goal, I would think. If delayed beyond that, there will be serious pps deterioration through the strong spread of FUD playing upon investor frustrations.
I agree that DI, et al won't move the needle. Results and timing will. My point wrt DI was that I saw much less incremental value for IR as opposed to a CFO that would inspire greater credibility since NWBO's financial house is not so much in order. At least, then, they could get their reports out on time and not make foolish misses because LP is wearing too many hats. JMHO.
