Friday, April 17, 2015 11:52:18 AM
Found this statment in Mar q4 results
Finally, with regard to PMA amendment for LuViva we have been told by the FDA that once a company has received the non-approvable letter which we received in September 2013 the FDA is not held to the same timeline performance standards as an initial filing, they due restart the clock but the 180 days in not a performance goal for the FDA. With that said they have missed several dates they provided to us verbally and in writing primarily due to other priorities including PMAs that were on the clock and nationwide issues that have risen including the UCLA Super Bug which also bumped our PMA amendment in their queue.
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