Seems clear there is room for improvement at EMEA and FDA.
Hard to fathom why they are allowed to function the way they do- seems outmoded, archaic; they're not ready for all the new science being done.
Talley talked in the CC about the possibility of new rapporteurs in the Ceplene case and a re-assesment. May be a further indication that there has been something wrong in this process. Since the former FDA Il-2 issue is resolved, there are no safety issues and no therapy alternatives, the whole background of this pre-vote is opaque. Talley said that the victims here were the patients and that many of them would die in a relapse.
Therfore IMO EPCT should make it VERY clear to the EMEA that the questionable opinion of a few members should not decide about life and wellbeing of thousands of patients.
MYGN seems to accelerate Axiza and the current delay is obviously not due to a legal impediment. The ASAP platform appears to move forward, in particular Talley mentioned promising aspects of EP 2407. The pain portfolio was not discussed in detail.
Yep, great questions, Synergy, and everybody else that took part. Thanks to all of you. Including you, Schantz, I know you felt a bit self-conscious there but your question helped too - nothing ventured, nothing gained - I think Jack's response to your question gave us a better understanding of where everybody's coming from, we all have doubts about what 'encouraging' means and now we know that it does mean something as far as Jack is concerned, so I'm grateful to you too.
Synergy, the discussion you started about the oncology drug assay platform was great.
I think we all know that epct is still a speculative stock but are more confident that the key players believe in what they are doing, which is important.
Thanks again, all.
>>Alot of good questions asked, and I thought mgmt did a good pretty job answering.<<
Very true- excellent session. I was a little surprised that the overall tone was so positive; I didn't sense any defensiveness, angst, etc. I'm not familiar with management's style though, so that may be just how they always are.
The one question I didn't hear (maybe it was asked), was if part of their Ceplene strategy includes going for the EMEA equivalent of FDA's "accelerated approval"; where they gain immediate approval subject to the results of a confimatory Phase IV trial.
Someone here (maybe you) suggested or asked about that option prior to yesterdays CC.
Will stay tuned to see if their consultant can pull another rabbit out of his hat and override the negative panel vote.
I must concure. Very nice job Synergy.
All the individual investors asked good questions.
Call me crazy, but I think we are going to get approval. Maybe in march, maybe in June, but we will get approval.