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Saturday, 12/01/2018 9:46:09 AM

Saturday, December 01, 2018 9:46:09 AM

Post# of 403296
It has been suggested that the BTD loss is no big deal and that I am wrong to make it so. Also suggested that not getting the BTD just means that FDA wants to see a longer trial and more data.

Of course there is a longer trial and more data required no matter what in the form of a P3. To me that suggests those concerns have nothing to do with BTD process at all.

At end of day will sit down and read more about BTD process but I thought a large part of it was trying to encourage push forward drugs where there is a lack of treatment options- in other words precisely what B OM aims to do
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