petition from t315i patients on the web, page-3

Diersel,
please listen to the ODAC panel hearing - it takes 4 hrs but well worth it - they shoot through that argument of offlabel use and expanded label indication. They state (and I'm paraphrasing here) that they dont want to give Omapro to patients who dont have the t315i mutation becasue there are other treatments like nilotinib and dasatinib that work alot better with less side effects. Hence why during the ODAC panel the discussion changed from approval to diagnosing the T315i mutation.

Specifically regarding failed TKI patients, take a look at the briefing documents - nilotinib and dasatinib get very high response rates...Omapro must get similar or better response rates. At the moment, the data we have shows ompro to be far inferior to nilotiniib or dasatinib.

The ODAC panel clearly state that the market size is only 200 patients in USA. Company has stated that it is 2500 patients in USA, 10x more than it actually is. All the analysts assume it is 2500 patients as well. Its as if the analysts dont do their homework and listen to the company with rose coloured glasses. My concern is when reality hits and anaysts finally wake up to the fact that the market is alot smaller than they think and they all smack a sell note on the stock.