IDMI @$2.53. EMEA (EU) decision in Q1-2009 (not Q4-08), with review in November '08. Now we wait another four to five months.
from tzm (partial):
<<This update has a lot of very good news but most investors were looking for the ultimate news of approval and so things are tempered by that.
Most of my limited brain power this morning has been going towards making a pot of coffee but what's left has me asking, why not approval then? I mean reliable data, no more CMC questions, and a positive benefit/risk assessment; what other questions could they have?
My read on things is that the CHMP wants to cover EVERY possible detail before it makes a ground breaking approval of the first immunotherapeutic oncology drug. This is a very big deal because it will be the first drug that uses the patients own immune system to attack the cancer. Not only is MTP a revolutionary new treatment option (which always faces opposition, i.e. Maha Husain) but it is also mired in questions because of previous application misteps and years of the data sitting in storage.
I go back to this L-MTP-PE story of the data never getting analyzed until many years after the completion because it is my belief that the scientific/regulatory world is a little bit shocked that something so important to thousands of sick children could have sat in storage for years. The consequence of this is that IDM is having to jump through many flaming hoops in order to get anybody to listen.
The FDA had already made up their minds before IDM even stepped in front of the ODAC panel and this combined with a sloppy application made Junovan an easy target for rejection. Walbert has learned from his predecessors mistakes and he is jumping through the EMEA flaming hoops with agility and determination.
No matter what happens, Walbert has done a hell of a job at getting the EMEA to listen and he is a very respectable champion of so many children who have randomly been dealt such an unjust hand.>>
