Replies to post #736360 on NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

The NWBO DCVAX-L for GBM phase-3 had a primary endpoint is progression-free survival (PFS), with overall survival (OS) as a secondary endpoint. The only end point in any trial is overall survival. Other endpoints are often chosen if it is believed they can convince the regulatory agencies that they are an indisputable indication that overall survival will improve in this case because progress free survival (the tumor decreased in size) means patients will live longer. If they only use overall survival then they have to wait years and years as NWBO did to prove overall survival increased. Unlike most chemo treatments that immediately shrink tumors we now know that tumors can actually enlarge initially due to the infiltration of immune system cells that work to kill the tumor. Progression-free survival (PFS) is not always a valid endpoint for immunotherapy trials because immunotherapy can sometimes cause tumors to initially increase in size before shrinking, a phenomenon called "pseudoprogression," which can lead to misinterpreting actual treatment efficacy based on tumor size alone, making PFS unreliable as a sole measure of treatment benefit in such cases; the gold standard for evaluating immunotherapy efficacy often remains overall survival (OS) instead . . . but you know all this far too well EX. Why are you again trying to mislead?

[flipper44]

In my opinion, this is what you’ll say upon any possible approval. “Oh, I see, I previously missed reading a paragraph years ago. My bad.”

[dennisdave]

Only after that did they change the endpoint. And doing so after an efficacy analysis is a cardinal sin in trials.

WRONG AGAIN this is just your biased opinion that is all.

Only after that did they change the endpoint

The FDA ALLOWS to change endpoints after AI study DoDo look at Anavex they changed the endpoints after datalock and have now submitted MAA. You were never able to quote the FDA where your rehashed BS statement is confirmed

They can change them whenever they want to. The issue is if an RA will consider the change to be a problem for a BLA/MAA.

You are completely clueless about FDA regulation. Again, the FDA ALLOWS endpoints to change/amend as long as the person who changes the endpoints(drafts a new SAP) is NOT biased from previous SAP/efficacy analysis. In there comes Duffy hired by NWBO.

YOU ARE CLUELESS AND A LIAR

[dstock07734]

How long have you been fixating your mind on this BS?

See this t-cell infiltration figure from neoadjuvant therapy of keytruda on rGBM in which Dr. Timothy Cloughesy and others found that administering keytruda prior to surgery can double OS than administering after surgery. The blue dots are cancer cells.


The following is the figure from the combo trial. Can you see the blue dots are a lot more than the above one? Do you know what it means?

It means that for the combo trial, complete resection of tumors may not be necessary.


Now refresh your memory about what I mentioned before.

[Doc logic]

exwannabe,

No, even if PFS had been positive the cost and limitations of artisan production getting past product release issues would have kept them from submitting for approval. Long term OS benefit would not have been established by them ending the trial early and would have left them seeking reimbursement with a lower quality life years assessment. Waiting, while very painful for investors, was the prudent thing to do as QLYs accrued and manufacturing at reduced cost caught up.
The best way to put yourself out of business is making and committing to an ill informed decision like you suggest. Unfortunately for you, Linda is just not that foolish or anything remotely close to that. Those that fall for your suggestion here, on the other hand…; ). Best wishes.

[Perk_Idaho]

Don't be in a hurry to respond fella's, he will be here all night, all day tomorrow, and everyday going forward until the deal is done. Tenacity..... at it's worst, wasted his life here... and he could have done something positive with it.