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Saturday, February 17, 2007 3:00:02 AM
Yes, thanks a lot for that remark concerning EMEA CHMP being the biggest hurdle in the EU MA process. This is what I was trying to convey. And because I wasn't clear enough Rod apparently took exception with my words and RTN's links.
The EMEA timetable FOR CHMP (emphasis added) points to approval this month or next month since apparently the 180 day hurdle has been taken without any major setbacks for INSM. (At least no SEC documents were published in the appropriate time period).
After EMEA CHMP positive opinion there still follows however about three month's of paperwork before the EU commission grants the actual Market Authorization (rubber stamping).
(Rod: Do not despair concerning the inner workings of the EU: I live in the EU now for 38 years and I learnt a lot extra of the EU inner workings by doing DD on INSM!)
Thus, if EMEA CHMP would give positive opinion next week, actual MA would be in may. Likewise if opinion would come next month, then actual approval in june. May, june timeframe is mid 2007, thus in line with INSM's own outlook.
As remarked by others a positive opinion of EMEA CHMP would dramatically change the dynamics if negotiations would be taking place between TRCA/DNA and INSM. Since other players, like prospect partners for INSM in Europe, would join at the negotiating table on INSMs side. Thus influencing all the 'hard work' by TRCA/DNA. (Irony factor: +1000).
Also interesting concerning possible negotiations going on would be the article in the NYT of today.
http://tinyurl.com/3b9gej
When reading this between the lines, there is clearly pressure being applied on both (or by DNA?) parties to settle their differences. (The article has a DNA slant to it in my opinion).
Sincerely, E.
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