Replies to post #1716 on FDA Plays

[gym gravity]

The data from this 1000 patients should be good for Mexican approval.

The comments in the last conference call and reiterated here indicate that Mexico already has data in hand and the company expects a response in about a month (from the conference call... so about april 15th.)

The other comment is that the company has been talking with the FDA. WHO has already recommended next year's seasonal flu shot will include A/H1N1 and NVAX has done a bunch of trials with their seasonal shot(s) so it's just a matter of one large trial next summer with the three recommeded strains and NVAX will be selling vaccine in the USA. I bet these FDA talks were about getting approval to run this next trial.

On the downside, NVAX just filed a shelf. They may be posturing, playing hardball with partners or suiters, saying "if you don't give us our price we are close enough to go it alone", or they may be getting the cash because they want to advance their RSV or Zoster vaccines.