Interesting post from the swamp: Barron4664
Post# of 72447
(Total Views: 371)
Posted On: 04/19/2018 5:17:20 PM
Interesting post from the swamp:
Barron4664 Thursday, 04/19/18 04:14:32 PM
Re: None 0
Post #
225140
of 225156
I think the posters both longs and shorts have all forgotten that Prurisol is not following a 505b1 AND to market. It has been approved by FDA for a 505b2 pathway to market. This is huge because under the 505b2 pathway a phase III may not be needed as the parent molecule is already on the market with a good safety record. So this study doesn’t need to be huge like many suggest. But I would expect IPIX do the most thorough job possible and include as many questionnaires as possible. Im sure they received guidance from FDA on what they wanted to see in this study. Everyone needs to chill.
Go IPIX!!!
Barron4664 Thursday, 04/19/18 04:14:32 PM
Re: None 0
Post #
225140
of 225156
I think the posters both longs and shorts have all forgotten that Prurisol is not following a 505b1 AND to market. It has been approved by FDA for a 505b2 pathway to market. This is huge because under the 505b2 pathway a phase III may not be needed as the parent molecule is already on the market with a good safety record. So this study doesn’t need to be huge like many suggest. But I would expect IPIX do the most thorough job possible and include as many questionnaires as possible. Im sure they received guidance from FDA on what they wanted to see in this study. Everyone needs to chill.
Go IPIX!!!
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