Replies to post #508298 on NorthWest Biotherapeutics Inc (NWBO)

[hope4patients]

This post is littered with false facts and misguided opinions.

[hoffmann6383]

Complete bullshit. NWBO saw none of the medical. This has already been litigated in federal court and this claim was roundly dismissed.

Not only did NWBO change to the gold standard in an impossible to treat brain tumor but they were the first successful trial in 400+ attempts and the first successful nGBM and rGBM trial in nearly 3 decades.

Not to mention we now have a RA that is modeling future trials off of NWBO's SAP. To insinuate issues in this area is simply bullshit.

Have a good one Ex. by.

[Dr Bala]

Checkmating after a highly successful P3 trial is an impossible task.

[sentiment_stocks]

The key is they cannot be changed based on data from the trial.

Whatever they based the endpoint changes on, it’s done. The SAP is the cement that seals them in.

Anyhow, we hear all the time in our lives how something can’t be done, and then it still gets done. A rather perfect recent example is that a president cannot forgive a loan, only Congress. And then the president goes ahead and forgives loans anyway, and for some, that’s good; for others, maybe not so good. But that move certainly appears to be breaking the rules.

My point is that rules are broken all the time… sometimes for good reasons, sometimes for bad ones, and sometimes for no reason at all. And sometimes there are consequences, and sometimes there are not.

Finally, beyond the fact that the UK and the EU who control their clinical trial sites and are the ones in charges of changing the sites - which they did for the P3 endpoints; the recent company PR about the UK PIP indicates that the UK is fine with the ECAs and the methodology the company is using to assemble them as they have accepted them in the PIP trial. It stands to reason, then, that they will accept them in the P3 trial. So even if you think that a rule has been broken by switching the endpoints to ECAs, many would argue it’s a rule worth breaking as DCVax-L has a statistically significant record (with the ECAs) of helping GBM patients live longer… for both newly diagnosed and recurrent.

[Doc logic]

exwannabe,

Very carefully crafted avoidance of “exceptions to adequate and well controlled trials” guidance will not achieve any hoped for point to be made. When the measures a trial begins with are the best available at the time but inadequate to properly quantify treatment effect, the exceptions rule can be utilized to demonstrate the issue and provide a potentially acceptable solution which can only be fully validated by actual approval based on it’s use. What this trial will demonstrate is that FDA and at least one other regulator interfered with trial powering based on a look at data by regulators that pointed to statistically relevant data that led regulators to the screening hold and non enrollment of the final 17 SOC/placebo patients. You argued that regulators were involved in order for this to happen at that time and I have not forgotten that, in fact I agreed with that. Good news turned into bad then, now back to good news with greater understanding presently of what was in play then ; ). Best wishes.

[Hspooner]

Oh what a tangled web we weave when first we practice to deceive'. Marmion, Sir Walter Scott 1808.

[dennisdave]

you are, again, falsely claiming that the rGBM endpoint as presented at the NY conference should be the same as the nGBM endpoint as approved and presented on the EMA/FDA website. I have already proved you wrong on that by copying both to see for you but you keep reporting this falsehood.


https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169688176


I guess you really are in need of reading glasses. No better reality check. From the NY Conference:

Secondary Endpoint: OS in recurrent GBM
Placebo arm crossovers* (n=64) vs. External controls (n=640)
*(Placebo arm patients received only SOC (control arms of external studies)
+ placebo until recurrence, then DCVax-L)

At the NY conference, the secondary endpoint for nGBM was not mentioned. Get a pair of reading glasses, +5 will do. If you are eager to learn with the second endpoints for nGBM is

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169688051

Monday, August 15, 2022
EU/UK and US endpoints do not differ

EU/UK/
The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence and control patients from comparable, contemporaneous clinical trials, in patients with recurrent GBM.

US
1. The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in recurrent GBM.
[ Time Frame: Until death ]

exact the same
It has been stated more than once by the company and LL that the SAP is the same with every RA

[biosectinvestor]

No, don't agree with anything you just said. And no, you don't have to unblind, or get the data that would be problematic to know that you don't have a placebo arm anymore to measure against. That is not data, that is just running a prudent, adaptive trial.

And again, they have adapted this trial as they went along, and the reality is, the regulators signed off on the end points and ECA before it was unblinded. You can try to make arguments, and try to make them sound legalistic, but it's bogus and you know it.

I am guessing, since the stock is back on the climb, the laid back approach you've had in recent weeks is over? Leaving it to the less informed of the NWBO critics isn't working out?