You made good technical point. What is the basis of your confidence? If you look at http://www.emea.europa.eu/htms/general/contacts/CHMP/CHMP_members.html
into the background of the members, the vast majority has no experience in oncology at all.
the panel is supposed to be completely neutral, and non bias....
If there was a non rectifiable material issue with the melanoma trial, then why was Epicept allowed to even submit an MAA?
This info has been known by the EMEA since 2003?
Why waste the companies time and the EMEA's time? If this was known from day 1, the EMEA should have refused the submission for this reason and asked for another trial, which they did not. Inexcusable if you ask me...
>So it seems the key is to get Ireland on board, or try to work around him. I still don't see how the rest of the CHMP does not object to the relavence of the Melanoma study. >
Syn, the problem are not the Ceplene results in AML, therefore something else hasn't been kosher here
I thought, given 16 months investigation, that the two rapateurs would have reached an consensus if or not to approve the drug. It would be nice to hear why the Swedish guy think that the studies submitted is enough and why the Irish guy don't feel so. Is the Irish guy only making his case refering to the melanoma study?
What's the name of this Irish guy? A person who is able to mix a melanoma with an AML treatment appears not a person of the professional medical community. Conflict of interests? Where is he consultant?
So it seems the key is to get Ireland on board, or try to work around him.
I still don't see how the rest of the CHMP does not object to the relavence of the Melanoma study. Maybe they will as time moves on.
have u slept any .i got 3 hours and runing on pure adrinaline in a bad dream why did they bring 2003 this is 2008 who brought it up steared others to have same vote and he is a bad seed maybe they were rushed it seemed like alot of appovels that day and some of chimps didnt really have enough time to really see the positives. it just easier too see the bad from past for a different study they need to just think on aml and not melanoma that is the key