Replies to post #133248 on Biotech Values

[DewDiligence]

why does Promacta have a REMS in the first place? I thought a REMS was reserved for drugs with side effect issues or at least a somewhat questionable risk/benefit profile. What are the specifics as it relates to Promacta?

That was the original conception for REMS programs, but it has become an out-of-control bureaucratic monster.

[ghmm]

Promacta/Nplate REMS:

I don't know of another example. However I am not trying to imply that there will be a sudden ramp because of that. I think that is A factor. I posted a sales ramp spreadsheet some time ago which shows the acceleration. My point was the change in the REMS, along with GSK seeming to be strongly behind the product even planned trying an indication where the trial was stopped for safety is very bullish.


Here is a link to the FDA announcement about the REMS note that is for both Nplate and Promacta.

#msg-69664587 or just go to
http://www.fda.gov/Drugs/DrugSafety/ucm280165.htm