IMO this third party manufacturer that got dinged is in India and Uncy wants that cost for there product….would another supplier meet this price…assuming my assumption is right….you’re 100% correct failure again would be devastating….uncy management better make 1000% sure they pass next time
Well the timing of the TDAPA application may be worth around $6m ...thats currently what they are losing per qt
Net loss attributable to common stockholders for the three months ended September 30, 2025, was $6.0 million,
Do agree tho that failure of re submission would be a disaster . I think our Ceo should move in and live in the manufacturing plant for a week before the FDA arrives to inspect ...so he's totally on top of it
EU was fine with the first manufacturer at the time of their inspection ...so they may be staying with that Co . Apparently there was only 1 issue FDA flagged