Friday, March 12, 2010 4:59:50 PM
Getting unexpected news about Exelbine as the official name for 530...
ANX closed up $.028 +13.33% with 30.5 million shares traded...
But just because the FDA gave 530 the brand name "Exelbine" doesn't mean a thing about the approval of the drug...
Applying for a brand name is a totally different kind of application than applying for approval of the drug...The FDA can approve the application for the brand name, and still reject approval of the drug itself...
The next big news should be that they've set the date for the sit down meeting with the FDA to find out how to fix the CMC issues that got the NDA application rejected with a RTF Letter...I don't expect much of a pop up on that news...
The next news after that should announce the date the company plans to resubmit the NDA for 530 by...The big question here will be is it going to be an accelerated or a normal time frame for the NDA?...
IF it's an accelerated process that only deals with the CMC part of the NDA, that would be fantastic news, and there should be a rather large pop up in the share price...It could move north until the actual NDA decision date like it did last time when it ran from .10 up to .50...
IF it's a regular review with a standard time of 60 days, that won't be received as well as an accelerated review...
Overall, after today I feel much better about my ANX investment than I did yesterday at this hour...
Have a great weekend everyone!...zz
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