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Thursday, September 02, 2010 6:21:19 PM
In Dean's last CC he stated he had conversation with the reviewer as recently as a couple days priopr to the call. At that time no further information or clarification on ANYTHING was asked for and the reviewer gave the standard response that the application was still in review.So, the issues asked for have been resolved, the FDA has asked for no additional information, and we are a week away from a guideline time frame for a response that the FDA has hit 100% of the time in the last two quarters. The new review team cannot share pertinent information prior to an official decision because they can't, but AGAIN, they have asked for nothing additional.
The current PPS for this stock is currently how much??? Is there any question the impact that this DVIS will have in the medical field once approved?? The logic it takes to decide which side of the fence to be on with this one is almost laughable, considering the risk / reward involved!! All of the negativity about how long this process has taken is completely understandabe, but if you look at where this process sits today, I would be very nervous being on the outside looking in as a critical date rapidly approaches.
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