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jaybe

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jaybe

Re: None

Sunday, 08/05/2012 11:01:06 AM

Sunday, August 05, 2012 11:01:06 AM

Post# of 80490
HB delayed the "complete" NDA on purpose...

Why would we file 99.5% and wait weeks to file "routine CMC data"? Haven't we been preparing the "minor, routine, technical" parts of application for almost a year now. Either it was incorrect and needs to be re-submitted OR...

HB intentionally delayed a complete filing to ensure our launch ready date of October 31st happens prior to early approval.

Also why would we be launch ready on October 31st only to carry those expenses for several months into mid-Q1'13?

Pona is already Fast Track and will no doubt get Priority Review status by mid-September. Remember there are NO available treatments on market for CML patients with T315I mutuation.

In summary I think we can expect approval by early December.


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