Replies to post #140256 on Biotech Values

[Superfly15]

Unless there's something coming up, I think time lag until any significant news is part of the problem.

[jq1234]

I understand both sides of arguments here. I just try to explain why the market value ECYT as the way it does right now.

I can easily poke holes into your argument. EMA conditional filing bar is very low, they even gave conditional approval to pixantrone because conditional approval needs to be renewed every year. As of FDA allow filing with PFS data, what magnitude of PFS advantage without survival trend would be enough for approval? Is 2.5-month (likely much lower in larger trial) enough? I am not sure.

We already know dissecting clinical data can be tricky and misleading. The data released in press release in this situation are just not reassuring to many people. EC145 certainly could work, I just don't know based on what I see so far.

[DewDiligence]

It has been reported that the FDA has provided ECYT with a written agreement that one trial will suffice using PFS as the primary endpoint.

Reported by whom?

[biomaven0]

So there must be something, even in the original data, that the European authorities liked

Well there was a very strong HR in the PFS data (less than 0.5 in the FR(++) group), and if you stratify the patients based on platinum sensitivity and other factors the survival numbers evened out even prior to the latest update (in fact there was a clear advantage in the FR(++) group). Also small numbers of non-drug patients and an exceedingly long survival in the non-drug arm.

As I commented a few weeks back on SI, I thought that they have a shot with the EMA with the current data, but not with the FDA.

Peter