P, they will get another chance to submit an NDA but it depends...

P, they will get another chance to submit an NDA but it depends on the reason for any subsequent CRL. A ruling against same product class rulings might be damning. A ruling against non-abuse deterrent IR products obviously now. So there is no extra cost concern here.

Preparing a quality NDA re-submission is an outcome of the CRL and not the use of an Advisory Committee.

What has perhaps cost us a little is that its taken a little longer to lockdown the path to approval. It was anticipated we would have the NDA re-submitted by end 2012. Looks like we will re-submit in Feb, a 1 to 2 month delay. Not that bad but yes, it has a cost.

On a different topic, trading has settled a little. Nice to see us holding the 100c level. The charts all look a lot better now too. Way off the overbought position we've been in recently. The weekly and monthly 5 year charts look great actually.

Have a nice weekend mate. Lets hope for another good one next week.