Several of you have indicated through mail you are disappointed with a post I made a while back . First and foremost, these were possible upccoming events based on Rabin's conference call. These were NOT my timeframes and I think the post is very clear on that. I have been here long enough and stated many times I don't put any weight in ACT timeframes. While it is approaching a month since CC, below are some explanations that may help.
#2)EU Orphan Designation(OMP meeting April 6-7) Obviously did not receive Orphan approval at April meeting. Maybe had questions that need answering and will possibly be done at May's meeting? Rabin would have to address the reason, I don't know.
#3)Roslin Deal No update except what was stated at CC(see below)
______________________________________________________________________ (post in question)
possible near term events,
likely near term events based on CC info two weeks ago tomorrow. Item #1 is the heavy hitter for me as starting trials is what ACT is all about.
1)Info posted to clinicaltrials.gov(will allow recruitment to begin) (CC quote) "and we expect their final approval within about two weeks."
2)EU Orphan Designation(OMP meeting April 6-7) (CC quote) "We have a preliminary indication that we are likely to receive orphan drug status in Europe, and are about to submit an application in Europe to their version of the FDA, the EMEA, for the same therapy"
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