Sunday, October 13, 2019 5:18:06 PM
So why would Elite be denied? Alcohol dumping test done, submitted, FDA inspections done, inspected facility twice in one year I believe.
If denied approval then there had best be a VERY good reason to do so.
An unbelievable reason to do so. And to me it would signal stone walling Elite/SunGen/Lannett. Just my opinion. Do not know why this would happen and would be sort of surprised if it did. Not completely though..... seeing the ineptitude with which the FDA has done things before. Nothing would surprise me. Pay for play.
Fact, there is no reason for denial. Even Lannett is chomping at the bit for this CNS approval. Elite/SunGen is ready as well as Lannett to get this out on the market with sales off and running.
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