Absolutely there will be a sell off. Third Party Manufacturing issues is an automatic Class II. That means the FDA will push the PDUFA date out 6 months. Even if it does come earlier, it won't be like a Class I which would be three months. The FDA are crooks. It will cost Impax $1 million to resubmit. They did the same thing to NAVB.
Correct, but the issue is that even if Rytary is not being produced at Hayward now or in the future, all product that was used in clinical trials was from the Hayward facility. That is why Rytary is being held up and also because the FDA is using it as the carrot for Impax to get there protocols up to speed.
The frustrating piece is that the letter was opened in May 2011 and almost two years later, the company still hasn't fixed the issue. Do they know what they are doing?