Replies to post #168208 on NorthWest Biotherapeutics Inc (NWBO)

[Turtle65]

The jury has been out for 2 years.....lmao

[GoodGuyBill]

With all the negativity aside, I think Linda is going to knock this out of the park shortly.....

Perhaps...But the Jury is still out.

I just don't think Linda would have plan this vote without the intent on release good news. If top-line is forthcoming, everyone will see her as a hero...again (even you)--GoodGuyBill.

This previously got a lot of hackle's up, but at the risk of hoping for resolution one way or the other, I have added to the list below, regarding reasons why it appears publication of final analysis could be sooner than later.

1. UCLA moved their conference from March to the middle of May which is after ASCO abstracts are released. This seems like a prudent thing to do regardless of simply DCVax-L's technology, because Doctors need to be able to talk to patients about commercial products, likely commercial products, new trials and other prospective therapies. Doing this after the bulk of abstracts are released at ASCO will allow them to focus on the therapeutics are still considered "promising." The most "promising" immunotherapeutic to Dr. Liau, beyond all others, right now is DCVax-L. However, pragmatically, it would be best reevaluate this promise after release of abstracts imho. If the promise is intact or bolstered, then great, but if it is diminished, then UCLA and Dr. Liau can move on to the next therapeutics -- which may or may not include DCVax-L combinations at that point.

2. Fraunhofer sounds a tad institutionally self motivated when they say it will only be after their last enrolled patient has received his/her final dose that NWBO's contractors will conduct an analysis of the trial, but nonetheless, they said it. If this was the plan all along, the carrot I've been chasing must be fossilized. Regardless, Fraunhofer is another source pointing toward imminent or recent analysis of the trial.

3. UK's N.I.C.E. has initiation of appraisal scheduled for mid June. In fact they just added
"Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators 03 April 2018 - 01 May 2018." Again, by itself, it could just mean another date that is bound to be moved again (as argued by the bears), but in relation to the trial data, it makes more sense than ever, imo, that even the tail will be sufficiently mature. Add this to UCLA, Fraunhofer and NWBO's prognostications, and analysis seems imminent.

4. Canada -- Even AVII thinks there is some chance final data scrubbing was accomplished on or around October 17, 2017. This information gathered from a public website calendar.

5. NWBO -- 233 OS events have certainly come and gone if one goes by Dr. Bosch's rate given last June 2017.

6. NWBO -- Either they are playing games, imo, or they really announced the upcoming vote intentionally after the last date for abstract withdrawal was possible, and set the date after ALL titles at ASCO will be released.

7. Preferred Investors -- The piper wants to get shares converted by June.

8. Cognate -- Expects commercialization soon for some cell or gene product.

9. Advent -- is/has negotiated DCVax-L, that's L, contracts with European countries recently. Is "migrating" to Sawston from London.

10. Sawston -- Physical site appears ready for manufacture and initial storage in main building, with additional 275,000 square feet available for expansion. However, personnel and resource "migration" from London will not be complete for another 15 months -- according to a job listing.

11. The trial. 48 months since median patient enrolled. 30 months since last patient enrolled. Eleven year old trial. All patients alive have had the opportunity to receive 10th (final) (or more) administrations of treatment and/or placebo by a maximum of early May. (More than likely 10th and final dose for last patient in the trial given some time ago.)

12. Optum RX...."And the post showing an indication of approval from Optum RX... That was real... From a respected independent source that has vast expierence..."(due diligence Evenstory)

13. Dr. Charles Cobb's statement on March 14, 2018, that the trial was under analysis and the final analysis had not yet been punished.

14. 2017 10K (released last night) -- Specifically states patients and physicians remain blinded. Clinicaltrials.gov has stated all along patients, caregivers, investigators and outcome assessors were blinded. One could infer, but not be certain, NWBO is stating Investigators and outcomes assessors are now unblinded.

15. Linda Powers -- Yes Linda Powers from a 2012 interview relocated by Lykiri (Originally located by John). She seemed, much more forcefully than I remember, stating both the U.S. and European data would be like separate data packages within the same trial, because manufacturing would be done separately in the United States and Europe (Germany/UK was her thinking at the time) She was very excited to eventually have both packages analyzed and submitted to both regulators at the same time in the United States and Europe. Reading that over again, it seemed pretty clear, in light of all the delays we've experienced , that LP was very attracted to two, not just one complete data set. It may be something she held on to intentionally or not. (While no excuse for other data lock timelines previously given, it was possibly one of the driving forces for waiting, see also #2 above.) To give some benefit of the doubt here, it may be 233 OS events and the last patient last dose of German enrolled patients were a little closer than we might otherwise assume.




(Other factors that may have contributed to delay might include, as myself and I believe Senti is mentioning, are that Optune kept releasing updated long term data that always seemed to slightly extend their numbers in a favorable direction. We are well past enrollment that could, if the trial DCVax-L trial was successful, demonstrate a better median than Optune -- if it is better. )--Flipper44