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Re: Sarepta Therapeutics FDA Panel Live Blog 

By: Decomposed in POPE IV | Recommend this post (2)
Mon, 25 Apr 16 11:40 PM | 99 view(s)
Boardmark this board | POPES NEW and Improved Real Board 		Msg. 05954 of 47202
(This msg. is a reply to 05953 by Decomposed)
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It's not going well. The FDA's Bastings is making a very strong argument that there is no sound evidence that the drug works. Sarepta could have done well-controlled testing and didn't. Its "evidence" has to do with how far patients can walk before and after treatment, but the assignment of placebos was not well controlled. 




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Gold is $1,581/oz today. When it hits $2,000, it will be up 26.5%. Let's see how long that takes. - De 3/11/2013 - ANSWER: 7 Years, 5 Months


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The above is a reply to the following message:
Re: Sarepta Therapeutics FDA Panel Live Blog
By: Decomposed in POPE IV
Mon, 25 Apr 16 11:06 PM 		Msg. 05953 of 47202

The FDA panel is going to make some sort of a decision this evening. Trading is currently halted.

I'm optimistic, but this could go either way. *IF* the decision is positive, this billion dollar company will have an additional $500 million in annual sales. The reward justifies the risk. I hope you guys have some.

Sarepta's eteplirsen *IS* safe. The only competing product was just shot down because it wasn't. The question is . . . is there enough proof that it works? Given that the victims are children and that there is little else that can be done for them, I think that marginal evidence of efficacy should still result in a favorable decision.

Now I'm waiting. Tick . . . tick . . . tick. 

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