Just an example re possible time frames for IND approval. Novogen (ASX: NRT) announced submission of IND with US FDA for Triphendial on 2nd December 2008 with subsequent announcement re granting of this IND from US FDA on 8th January 2009 (37 days). This was also over the Christmas/New Year period as well, not bad time frame.
Also, Prima have gained the services of very experienced people to manage this application which may or may not reduce the time frame, but should ensure no unecessary delays along the way. I don't know if Novogen had to ammend any part of their application in the above time frame.
(apologies if further research finds the above example is not relevant, first one I found)
Remember though, we are also hoping for Orphan drug status and favourable trial parameters as well. I am not expecting this to delay the result of the IND application, however this will be exciting news if received and released at the same time.
Regards.
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