Replies to post #288882 on NorthWest Biotherapeutics Inc (NWBO)

[mxp1]

NWBio needs a new strong manager/CEO. Once FDA approves, price will go straight up. We now have eighty locations able to treat GBM with DCVax. From there I do believe most hospitals that perform Cancer and or Brain Surgery will want to use DCVax.

[GoodGuyBill]

i think what is understood by the term, "go it alone", is simply that NWBO is not bought out. Multiple partnerships, where NWBO could use the expertise of numerous BPs, falls within that term. For example, NWBO is going it alone right now...but it used Merck/Duffy to develop the SAP, right?

Also, wrt the length of time the p3 trial has taken, (1) early on during the trial there was an economic collapse when the trial was on hold, (2) covid19 also impacted trial hospitals which were on focusing on patients with the virus and stopping the spread of the virus within its walls. But the main reason for the long time period has to do with the fact that (3) NWBO was not aware of some aspects of the DCVAX treatment like Pseudoprogression and the long tail effect and (4) the DCVAX treatment did not align with the FDA's current drug/trial mechanism, hence the redesign of the SAP and the new FDA guidelines that seem to have been written with NWBO's DCVAX trial in mind.

So, IMHO, your position that NWBO/LP will take too long to go it alone because of how long the L trial has taken, may need reconsideration. First, NWBO/LP and the FDA (because of the L trial) has learned a lot about dendritic vaccines that will, in future trials, eliminate much of the inefficiencies in the current trial. Second, there is now a specific roadmap (i.e. the current SAP and new FDA guidelines) regarding how to design a trial and how it will be validated, respectfully. Third, the L trial will result in an enormous collection of data. As a result, pseudoprogression will be expected and quickly validated via new methods validated in the L trial data results. Also, it is likely that the new SAP as well as trial data will bring about the use of biomarkers to help evaluate drug effectiveness instead of having to wait for the trials long tail.

Do you think it may be necessary to reconsider your position?

“Better yet go it alone.”

Hilarious. So their “go it alone” timeline to PMA submission would be, what, another multi-month process (read: 3-5 years). Once approved, I’m sure they would have a “soft” launch and target 2-3 hospitals over the first couple of years, because “Linda wants to make sure she gets it right”.

Their go it alone Strategy may only take another 10!years. THEN they can shift their focus to Direct.
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