If the math cannot be done, how can competent cost-benefit decisions be made regarding investments made into the ANDA's based on potential return? All assumptions are simply probabilistic. So we can play "what if" we get 50% of the Oxy market or 5%, and either case assume getting such a market share against very competitive BP's would be easy, and then multiply fraction/segment by the market size, make assumptions of the total cost of goods sold, thereby derive assumptions of subsequent profit to then be divided in half with SunGen. This is assuming, of course, we get a go on the manufacturing facility, and then further assuming the ANDA's actually approved. So, you just got to use a bit of imagination for the sake of assumptions here, and it's a whiz-bang flight to Dollarland.
The thing that didn't quite seem right to me was the FDA holding off ANDA approvals until manufacturing facility approval. Usually, they approve formulations separately, and then the onus of a cAMP facility is on the producer, who must then first garner approval before manufacturing. Not deciding approval/dis-approval until the facility warning is completed does not quite sound right. How long has this ongoing warning letter been going on now--like a year...and still unresolved...and knowing this, Nasrat sat/let sit the ANDA approvals? Smells wrong.
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