InvestorsHub Logo

UpstateChris

12/31/10 12:50 PM

#8572 RE: mqwlaser #8571

Laser -

Thanks for the additional info.

In regards to "commercial quantities" of 514, I am absolutely sure that neither 514 nor 530 have been produced in commercial quantities. Not being in the marketplace there would be no need to do so. The key is that the intended commercial manufacturing facility, using the intended techniques and formulas, manufacture small batches for stability testing. I have read PR's from over a year ago that this was in fact being done. So unless they have changed manufacturer's or techniques (could be possible - I took a few months off from following ANX)they should be good on this.

In regards to the meeting, you may very well be right - I can easily see where it could be read either way.

What does concern me is the meeting itself. While the PR does not go in to details, it is not a normal step in the NDA submission process. This could be ANX being overly cautious after the 530 RTF letter - it could also mean that something is borderline and they want to see if it will squeak by. Dont really know there.

If you happen to have any links you can reference to public information about the delay in 514 handy, I would appreciate them. Otherwise I'll just hit Google and see what I can find.

Again, in the short term, 514 is meaningless. No one has any delusions that we see any real price action due to 514 in the next 6-9 months anyhow. Let's see what 530 does. Who knows, if 530 is accepted we may see a buy out bid before 514 ever gets close..

Thanks and Good Luck