Is that the date for this drug? For a different use than it currently is used for??I cannot seem to find info on it..Anybody know?
Should have been clearer. I was referring to the 3 day dosing MDS trial which failed on OS which also happens to be the same endpoint as the AML trialhttp://www.eisai.com/presskits/EORTC%20Release%2007%2001%2008%20PM%20FINAL.pdfThe AML trial is a 5 day dosing trial but if anyone has an opinion on the significance of the dosing would like to hear it. It appears that based on last years ASCO the 5 day dosing has a significant difference over the 3 day.
Jelly While they would technically receive a patent extension in reality the generics would just carve out the new inidcation from the label and come to market at the time the original patent expired.
The FDA is looking at the data for the 5 day dosing. Currently Dacogen is approved for the 3 Day. We are also waiting on the results from the aml trial, this could be annouced anytime soon.
Will the new Dacogen FDA decision increase revenue and by how much if it's approved??