I e-mailed the emea and asked about the date for the oral hearing, this is the reply:
The oral explanation of Ceplene application will take place on February 20th at 14:00.
My best regards.
Safety and Efficacy Sector
Just thought board would like to know.
yes, but are you sure that the press releases at the end of the monthly meetings cover applications that go up for oe during those same meetings? perhaps those month end prs are for applications that went up for oe during the prior month's meeting? i couldn't verify this one way or the other. logistically, it seems odd to me that a government committee can get its act together so quickly (one or two days) following the oe, but then again this is europe and maybe they do things much quicker there than in the us. can you verify that?
excellent dd, folks...
...so if the oral explanation is on feb. 20, when do we expect that they will issue their opinion? could it possibly be the next day???
take a look at the january 2008 calendar, and then look at all of the january 2008 opinion dates.
all of the january opinions were issued on the last day of the meeting block for january.
maybe the opinion will be issued on the last day of the march meeting block -- march 19?
wow...getting really close...
lol...don´t worry they will confirm it or at the latest at the presentation.
But ceplene will go for the chmp on the 20th. You will see.
On another note, if we get a positive opininon, are we guarantied an approval??