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Re: MONEYMADE post# 1342

Tuesday, 01/14/2014 8:12:08 PM

Tuesday, January 14, 2014 8:12:08 PM

Post# of 3033
think you might need to light one up and chill on the caps.

stock trading from 2s to 6 on advisory panel reco is a bit much given FDA concerns. long side tomorrow will be extremely risky.

In the document, FDA staff wrote that the decision whether or not to approve droxidopa is "complex," noting that strong evidence from one clinical trial indicates that droxidopa confers "at least one week of symptomatic benefit," but also that there has been no durable effect, i.e., more than 1 week, demonstrated for droxidopa. The document also notes that Shire (SHPG), the sponsor of midodrine, an approved drug for symptomatic orthostatic hypotension, is currently being tasked with completing 2 adequate and well controlled trials to demonstrate that drug’s symptomatic benefit. The document also states that there were "numerous concerning safety findings" related to droxidopa.

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