Replies to post #535090 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

Anyone judging whether a trial should be repeated has to see not just whether there were errors or mistakes (since any human endeavor will likely have some error or mistake that those with interests on either side can point to).

Instead, it is not a question of whether there are mistakes or errors but whether those are reversible mistakes or errors.

Any issues with the trial in question while not ideal, are not reversible errors or mistakes and the remedy is not to force a cash-strapped company to repeat a trial or to force more people to die a lingering and painful death over the next 10 years while we wait for that study to be repeated.

Given that DCVax-L has an excellent safety profile and given that there is presently no viable treatment on the market and no other treatments within striking distance of approval, the FDA is highly likely to approve DCVax-L and watch carefully to see whether the results of the trial prove out in the real world.

If the results do not prove out with patients in the the real world, and DCVax-L proves extremely ineffective they can of course revisit their decision to approve. Still as we have seen with the 'helmet' the standard an approved product needs to meet to stay approved (provided not additional safety concerns arise) is pretty easy to meet.

So while you're suggested remedy for trial issues is appreciated, it is really not practical or humane or in the public interest.

[biosectinvestor]

There were no “mistakes”. The crossover was required by the FDA. That pseudoprogression as it was and apparently still is measured was useless was a fact of the limits of science at the time. None of the regulators are going to be as ridiculous. This non-stop and false crusade of some is bogus and a distraction.