Wednesday, January 02, 2013 11:29:55 AM
I will caution that CMC can really muck up the process though. Don't know if you are familiar with Discovery Labs - they have a really good product - surfaxin - that the FDA seemingly just didn't trust on the manufacturing side for about 3 straight years.
And yes, price should precede approval.
My "too early" was really directed towards using PE or sales estimates prior to HEAT data. Once we know what we are dealing with, it is MUCH easier to construct models.
Best,
Trond
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