Media Thread, page-5399

@davybabyk

(tried to reply yesterday, but HC was not working for me).

Hi Dave,

I did read your post, and yes if shortening the Phase 2 trial accelerated the commencement of a registrational trial then I agree it would be ethical.

However, I can't see or don't agree with your logic. If the results from 36 patients is sufficient to progress to a registrational trial, then why not just take the data from these 36 patients to the FDA and apply to start the registrational trial, while still continuing with the Phase 2 trial?

In that post you also pointed out:

"My interpretation: the "strong signal" is a reference to the "overall favourable survival outcome with no toxicity" and the IDMC is saying that scientifically the study has already shown that HER-vaxx is beneficial to survival, so they should just shorten it by restricting enrolments."

This is the crux of my issue with the IMU announcements and Leslie's interviews. Your interpretation may be true but the issue comes down to how strong the signal is. It might be that its strong enough to justify a registrational trial to the FDA or it might be that its only strong enough to justify combination Phase 2 trials. IMU has simply not been clear on this.

I also note that the company has announced its intention to commence three new Phase 2 HER-Vaxx combination trials, but has never mentioned its intention (or even the possibility) of a registrational trial for HER-Vaxx.

Finally, there's the question regarding a p-value that would be acceptable to the FDA to approve a registrational trial and whether this is achievable with just 36 patients (my view is that if it were, the trial would never have been designed to have 68).

So sorry, I should have noted that you were in fact the only poster that did address the ethics issue, but I just wasn't convinced by the argument!

Thank you as always.