It won’t be declined,fda approves everything,this time was classified as “A class request “ FDA told them exactly what to fix(it’s common to have multiple labeling/side effect insert sheet changes to just change some words)most are approved around 20 days (12-30 days,”A class “is top of list turn around time) OTLK is hiring ppl here in USA to monitor the drugs side effects when ppl take it(they wouldn’t do that unless they knew it was going to mkt!) Germany/Europe/uk ,also hiring many positions,reps. To promote it! They have the largest drug manufacturer and distributor(ticker COR) in the world to get it into pharmacies, they have all their ducks in a row,this is happening and don’t believe the buyout b/s ,OTLK is taking it to mkt and planning on making tons of profit
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