The data issues are pretty typical of the things that go wrong...

The data issues are pretty typical of the things that go wrong in the real world. The crucial thing here is that the FDA are saying that the data are fit for the purpose that is being decided on. So no I don’t agree with you on this.

But I do beleive the vote will be no.

The Adcom members being good “lay” reviewers have got exactly to the heart of the issue. Study 22 does not provide the level of evidence typically required from a pivotal P3 study that is about confirmatory hypothesis testing. What has been presented is descriptive. And that the study missed it primary endpoint. This basically precludes approval because this is virtually impossible on secondary end-points.

QRXs response to this will be that the FDA informed them that they should explore the data in Study 22 and if a safety advantage could be found it would be considered. QRX still partly cling to the notion that equal efficacy and safety should lead to approval under the combination rules – even though this has been rejected twice.

The FDA as the “professional” reviewers will highlight that QRX first tried to show superior efficacy but failed. The fact that a SPA was not agreed will also feature. Adcom members will seek clarity from the FDA about what exact standard should be applied ... which I suspect will be one (not the usual two) P3 study – with agreed primary endpoints, sample size etc.

And this study will be funded from the $15m QRX have left in cash. Historical data tells you the probability of approval after 3 CRL is very very low. And QRX will priced accordingly.

Will wake up tomorrow and hope to find my predictions completely wrong. As they often are.

Good luck Southoz