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.
