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From the FDA website, there is only BAX doc. Without FDA doc, we dont know what are FDA going to criticize. Why there is no FDA doc?
Hi, there is only Baxter briefing doc on the FDA website. What about FDA briefing doc? I am more concern about what is the question FDA going to ask and committee need to vote for.
From the press release, we know that BLA had bee submited in Dec 2013 and required 6 months review. So, any specific date for approval ?
Any latest scripts data update here?
Any Imbruvica sales figure from JNJ earning release? I cant find that.
Thanks for the reply. Insulin Market is huge, this is big for HALO. GLTA. I am long HALO now.
From the recent press released, after the enrollment completed. They expect the data release in early March , and file the NDA in end of March. Am I correct?
I am new to this stock. Need some info here.
According to the earning transcript , HALO going to announce the PHASE IV study for Analog Insulin - PH20.
May i know is the product in the market? Cause it is in PHASE IV , a post marketing trial?
Or it is not in the market yet, we still need to acquire FDA approval later?