I am calm - I'm simply calling you out on what I consider to be an incorrect assessment of the situation. There are a number of examples of the EC allowing drugs on the market before the FDA and there is no reason to believe that the EC is waiting on the FDA in this case. Your characterization of the FDA is a bit simplistic - like most govt agencies, they aren't attracting the best and brightest and political/monetary influence can play a significant role in their decisions. Your implication is that there is something controversial or missing from the data that FOLD has provided the agencies and these delays are warranted because of these shortcomings. I choose to believe that the data is substantive enough and they are just getting the normal, capricious bureaucratic treatment that most companies do, possibly influenced by pressures from Genzyme.
Regardless of how you perceive JC, the idea that the EC is waiting on the FDA is senseless. Is JC too enthusiastic about the prospects for Migalistat - possibly, but he is in a position of knowing that the drug works, has substantive clinical data supporting efficacy and safety, and unless he is lying, initially received positive feedback from the FDA on whether their data package was supportive of approval. No doubt, he has toned down the enthusiasm - other than saying that he was proud and happy with how the team dealt with the oral presentation at CHMP, he offered no positive spin or speculation on the prospects for approval. What comments from today's call require a "heavy dose of salt"?
#$%$ are you talking about - what does Listeria have to do with Migalistat? As the CEO spoke about on the call, the life-threatening issues of Fabry are renal and heart issues, which was the focus of the data package that they presented to the FDA last year. Then, out of left field, the FDA decided they wanted to see data on the impact of Migalistat on GI issues - Fabry apparently causes serious diarrhea, which is not life-threatening, but a quality of life issue.
IMO, this is just another case of the FDA protecting an established market for big pharma - in this case Fabrazyme from Genzyme. It was clear from the Migalistat clinical data (the largest phase III studies ever done in Fabry) that Migalistat was at least as effective as ERT in dealing with renal complications and better than ERT for heart complications. When it comes to quality of life issues, Migalistat is an oral medication, while Fabrazyme is an IV infusion every two weeks. From a safety perspective, many patients can't tolerate Fabrazyme due to adverse immune reactions. The delay by the FDA is a travesty.
Your post makes no sense. They are expecting a CHMP decision next month and they don't have a meeting with the FDA until next quarter. The EC is not waiting on the FDA opinion - that won't come until 2017.