Replies to post #774390 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

AI, There’s no assurance that the PIP is still green lighted since MHRA is now reaching out for opinions on EC PLD standards. It’d also explain why no pediatric L trial has even begun yet.

>>That’s just false. The pediatric plan explicitly adopted the adult trial design, including its control methodology and endpoints. Adjustments in secondary endpoints do not change the fact that the survival analysis structure, the backbone of both trials, is shared.

[exwannabe]

2. “Prespecified means before enrollment.”
Yes, and that’s exactly what happened. The use of external controls was pre-declared in the adult trial’s protocol and approved by regulators. The MHRA’s own guidance talks about prespecification because it’s a bar for trustworthiness, not a gotcha. DCVax-L cleared it.

It is more than a bar for trust. It has to do with bias and multiplicity. And the fact is, on this importand issue there is a huge difference. The PIP abides by the guidance while the P3 did not.

1. “It’s not pivotal.”
Irrelevant. The significance isn’t in the phase, it’s in the MHRA’s acceptance of the evidence mode

Wow. So you think the RAs require every P1 trial to have a plan that establishes efficacy? The vast majority of P1/2s do not have plans with solid proof of efficacy.