Replies to post #204242 on NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

If...if they have a potential partner lined up, then that entity is dictating the timeline. Being a newcomer onto the scene, such a potential partner will be inclined to have a bit more patience, say another 6 months or so (to ensure higher probability of success) then we long-suffering longs are able to afford.

I think the SAB and not a potential partner is advising LP when to unblind the trial. With or without a partner, NWBO has no choice but to wait as long as it is necessary to maximize the chances of this trial's success. NWBO will have to inform any partner the estimated additional time it will take to ensure the maximum chances for the trial's success. The potential partner will then take this into consideration.

I believe that we will receive top line sometimes between 3/19 and 6/19. By June 2019 all patients in the trial will be at least 46 months past their surgery. The 2017 publication established that of the first 223 patients 67 (30%) lived 30(+) months and only 50% of those 67 (33 or 34) reached 46.5 months alive. After 46.5 months on trial the attrition rate was greatly diminished. That is shown by the fact that of the first 182 patients enrolled 44 (24.2%) survived 36(+) months but the derived mOS of those 44 patients was about 88 months. In other words 22 of the 44 patients would survive 88(+) months. Since at 46.5 months we had theoretically 33 or 34 patients alive and 22 at 88 months, we would have lost only an estimated 11-12 patients between 46.5 and 88 months.

I therefore believe that NWBO could do no better than data lock at about 46 months past the last enrolled patient's surgery. Going beyond that time would serve no purpose at all.

[doingmybest]

If there is a partner lined up the partner could even offer technical support under a consultancy type of arrangement, and, of course an NDA, if NWBO was comfortable with this type of sharing. The relationship would have to be far along for it to occur. The partner would have the opportunity to suggest or recommend a longer time frame if beneficial but of course NWBO would have final say and I think if any such deliberation has been undertaken by NWBO that it has already occurred.

It is very hard for me to imagine any scenario whereby NWBO could continue to mature this data and I also believe RA's are asking when they will unblind. Of course I have been surprised by their extended timing already, I had thought unblinding by 11/18 with an outside chance of 2/19.

Rkmatters had this one nailed with the extension to 11/18 prior to data lock.

This is an amazing story of hold, hold, hold, now!