Tuesday, February 26, 2008 8:13:03 AM
Actually, you just said the fact that they wanted a new IND was scary. So, I would place a pretty high value on the probability NON ACCEPTANCE in just that term alone. Scary, means that fear is involved and the only thing that would really HURT is if the FDA said "no". That would be the only scary scenario.
Actually the great thing about the word 'scary' is that it is so nebulous. For instance perhaps there was an underlying tox issue and the FDA wanted an excuse to run more animal models? But obviously, now that the IND is out, most of the 'scary' scenarios are put to bed - even the ones not tied directly to not getting the new IND. But perhaps it is just my lack of imagination - it will be interesting to see if Dew still sees any specific scary scenarios.
Actually the great thing about the word 'scary' is that it is so nebulous. For instance perhaps there was an underlying tox issue and the FDA wanted an excuse to run more animal models? But obviously, now that the IND is out, most of the 'scary' scenarios are put to bed - even the ones not tied directly to not getting the new IND. But perhaps it is just my lack of imagination - it will be interesting to see if Dew still sees any specific scary scenarios.
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