did they not run a 2nd trial because they thought the data would not confirm the original trial's findings?
Where is the logic in that that confirmatory second trial results would be poorer? With current titration practices, drop-outs would be expected to be lower. With patient eligibility criteria tightened to include more early stage patients, positive efficacy would likely increase. With larger patient numbers, the positive effect data would be expected to increase.
The EMA is is a bureaucracy. 60 people, 2 from each country, will vote on the blarcasermine recommendation
Where did you get that info? The CHMP has 30 voting-eligible members in total: 27 members appointed by EU Member States plus 3 members appointed by EEA-EFTA States (Iceland, Liechtenstein, Norway). Each member has an alternate who can vote in their absence. Up to 5 additional co-opted members may be appointed for expertise, but they are non-voting. So, it is thirty voting members, not 60.
Hoskuld That was the first and most complete response I have read!
I was not aware of the diversity of the CHMP regulators from various different countries and assumed that it was a group of people who actually did know Sabbagh, Gabelle, not maybe Jin...so that was an eyeopener especially when you said that you doubted that they were even aware of who they were!!!
I am shocked that especially Sabbagh and Gabelle were most likely unknown to them (damn, what an uninformed group of "regulators" !!!).