Ou71764, I want you to read the following from Vermillion which goes back to an alliance agreement between Vermillion and Quest as follows.
On July 22, 2005, Vermillion entered into a strategic alliance agreement with Quest pursuant to which the parties have agreed to develop and commercialize up to three diagnostic tests. The term of the agreement was set to end on the earlier of (i) the three-year anniversary of the agreement, which was July 22, 2008, and (ii) the date on which Quest commercializes the three diagnostic tests. On July 21, 2008, Vermillion and Quest amended the strategic alliance agreement to extend the term of the agreement to end on the earlier of (i) September 1, 2008 and (ii) the date on which Quest commercializes the three diagnostic tests. Subsequently on October 24, 2008, Vermillion and Quest amended the strategic alliance agreement to extend the term of the agreement to end on the earlier of (i) September 1, 2009 and (ii) the date on which Quest makes its third development election. To date, Quest has selected only two diagnostic tests, which are peripheral artery disease (“PAD”) blood test (“VASCLIR™”) and ovarian tumor triage test (“OVA1™”), to commercialize. Vermillion’s major initiatives are currently aimed at commercializing these diagnostic tests, both within the context of its strategic alliance agreement with Quest as well as markets in which Quest does not participate, to the extent permitted under the strategic alliance agreement.
Ou71764 now I want you to look at the following which I pulled from a different area within Vermillions filings. Now remember we were looking for one type of filings from Quest and a 510K filing from Abbott. Now I'm no doubt NOT the smartest man on the block which is as said but look deeply here and look.............Vermillion NOT Quest or NOT Abbott filed their 510K application with the FDA referencing the OVA1 test in June of 2008 and the FDA cleared the test on 9/11/2009.
My questions are firstly if it takes basically 15 months to get FDA clearance after the 510K is filed then how long will it take us to get in a position so we are able to do our 510K filing? Now really listen closely? we all know that we have an easier route to take than doing any 510K application filing yet why in the World (even with Quest backing Vermillion with money guarantees) did they not go the easier route or was it not available in 2008. Next!! if there is any political BS going on to slow up our debut/test will Quest now FORCE us to follow suite and push us towards the slower filing which of course we all know is a 510K application.
I sincerely do hope a few here with the market/business related knowledge can weed through my post and see just how deadly the plate may or may not be. I sure wish that LTDcoverage would post about this concern but if it is too hard to understand my writings then I would no doubt need to explain this over the phone but I must tell you I have far more concerns about this post here and translated thoughts to this than of course Mr. Quirk's warrants.
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