There is no doubt that fi-ASCO was a not too veiled warning that SAP approvals and top-line are not around the corner and that there is still a relatively long way to go.
Dr. Bosch described the development of the SAP and the involvement of a page team of consultants, oncologists, professional statisticians, etc. in putting together state of the art analytical tools for a complex and pioneering SAP. Developing this SAP was one ginormous project comprising perhaps a 100 pages and is still uncompleted and not submitted to the requisite RAs. With its state of the art, pioneering and complex analytical tools and various end-point/objectives to be met within this SAP protocol, one has to wonder whether the RAs are well acquainted with these state of the art methodologies, have sufficient resources in order to review, digest and understand what is in the protocol and then come up with questions, comments and suggestions in a relatively expeditious time-frame. As it was a ginormous task for NWBO and its slew of experts to put this SAP together, it is reasonable to assume that, likely, it will be a ginormous task for the regulators to ultimately come to approval. Perhaps the reviewing task is not nearly as ginormous as was development of the SAP by NWBO, but with limited resources and other competing priorities, one can be reasonably certain that the turn around approval time will be protracted.
Accordingly, in my opinion and it is only an opinion, the goal posts have been changed once again. I believe that NWBO management is now conservatively looking at SNO to update SAP progress and that they are pointing for RA approvals by that time so that they can make an appropriate announcement. By that time, the queries should be mopped up and data lock follow shortly thereafter. I believe that it will take a couple of months to analyse the data even for top line release which I think might take place in the January/February 2020 time frame. An abstract will be presented with fully analysed findings in time for ASCO 2020. Assuming that the results are positive, I foresee RA approvals toward the latter part of 2021.
Keeping in mind NWBO's pattern of relative non-disclosure, we will not have SAP updates until, at the very earliest IMHO, SNO. Between now and then, I see further erosion of the share price to new lows if not the upper single digits.
Fi-ASCO confirmed to me, at least, that LP is not in the least concerned in defending and preserving the share price. LP believes in market value which will ensue if the trial is successful. Until then, she does not care if the share price is $0.25, $0.15 or $0.05. If the share price is at $0.05 at the time of approvals, no matter, as the share price will eventually over time reach an appropriate level. Accordingly, in LP's mind, this is a very looooooooong term investment and even bothering to "protect" the share price now is a waste of time and resources. While I did not, in the least, expect top line to be announced at fi-ASCO, I thought that more encouraging news could have been announced for share price protection. For example, wrt to the SAP, Bosch could have been allowed to give a more encouraging SAP explanation and a time frame that while not completed, they expected completion and submission to the RAs within the month of June and knowing how important this info is to shareholders, they would update on their progress. Wrt the queries, Bosch could have been more specific, i.e., "we have about 250 queries left out of the nearly 15,000 total that we have worked through and expect that these queries should be mopped up by the end of June. And on another piece of news, the number of patients still alive are 76 with an attrition rate approaching 1.254 patients per month." I believe that even this parsimonious revelatory presentation would have served to minimise share price destruction.
The presentation on D, at least to investors in my network was all but ignored. It fell on deaf ears because interest was keenly focused upon L. And investors know the state of D trials. They get announced and then swept under the rug. So D was obviously a placeholder because NWBO had so little to say about L. D was considered to be nothing more than a diversionary tactic for the lack of really meaningful L information.
With fi-ASCO now gone, NWBO management credibility is virtually non-existent as is BOD Jerry what's his name. At the ASM, he was heard to say that we should be expecting news with 3~4 months and that we need to get the share price up before we can do a lot of things or words to that effect. ASCO was a fi-ASCO and an opportunity to say something more than the ill-crafted presentation Dr. Bosch was surely forced to make with LP no where to be seen. She let him be run over by the bus and may have severely impacted the only member of management who had any credibility. I can understand why Dr. Bosch was nervous.
And now we come to Mr. Innes. I have consistently felt that his hire is/was premature. Essentially, he is an expensive cushion for LG who has other priorities and has tired of minding hoi polloi shareholders especially MB denizens. Enter stage left and we have Mr. Innes. He has fashioned himself as he has told me in a phone conversation that he is a shareholders' advocate. With his experience and market knowledge, he knows about value preservation and attracting/keeping investors relatively pacified and interested. The last thing he would want is to work in an environment where management does not give a damn about preserving share price at all. And if there is no real news at all, what is the sense of having IR in the first place? There is nothing to say except he left his old job convinced of the efficacy of the science and what a great opportunity, blah, blah , blah. All nonsense and an endorsement by a non-expert in the science. What would be convincing is a change, indeed any change, no matter how small in the non-transparent culture of NWBO management. We saw none, nada at fi-ASCO.
Did Mr. Innes know what Dr. Bosch was going to present? Did he provide a counter-suggestion at least along the lines suggested above? IMHO, Mr. Innes had a chance to utilise his experience and expertise wrt the investor community and share price preservation and what we got was nada, unless he believes the presentation was the right way to go in the first place or equally as bad he had no influence otherwise. Perhaps nobody listened to him. So in my view, fi-ASCO has in a way resulted in NWBO management's undermining his role in IR where his very credibility and real necessity for IR is in question. Frankly, I personally would not believe a word he says because he is parroting the company line. He is LG wearing another suit and IMHO a wasted resource costing NWBO money it really does not have. I don't really blame Mr. Innes but I think he got himself into a situation not of his making, underestimating how influential he could be in engendering at least some change in the culture. Rather, whatever value he may have potentially had is now quite suspect after fi-ASCO.
All in all a very disappointing fi-ASCO. JMHO.
