RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RBCI thought the original explanation given for delaying F4 was along the lines that the wanted to run down and manage the original formulation stocks.
Maybe the earlier manufacturing blunder has pushed them to a much more conservative approach that keeps the old formulation stock high enough to cover any eventualities that might arise from the introduction of F4. If they are doing stability testing there is always a possiblity (however small) the testing throws up a problem (after all thats the point of doing the testing). Maybe they are covering their backs better this time, ensuring the older formulation covers any problem period and they dont end up with a period of no stock. That might lead to a longer introduction time, idk. Do we know if any actual problems have been encountered? I actually missed the first 10mins of the cc, I'll listen again, did they say there was going to be an added delay?
palinc2000 wrote: Poor
can you offer an explanation as to why the F4 formulation which was approved last fall by FDA wont be made available until Oct at the earliest?