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Re: Sarepta Wins FDA Nod For Embattled DMD Drug -- But With A Catch 

By: Decomposed in POPE IV | Recommend this post (2)
Mon, 19 Sep 16 9:14 PM | 56 view(s)
Boardmark this board | POPES NEW and Improved Real Board 		Msg. 11289 of 47202
(This msg. is a reply to 11287 by Decomposed)
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My enthusiasm for Sarepta waned considerably over the last few months as I learned more about its product, eteplirsen, its chances for approval and the size of the potential market.

One of the downers is that Duchenne Muscular Dystrophy afflicts just 14% of the MD patients. Right there, 85% of the potential profits evaporate.

Then I learned that a drug that works in a similar fashion already exists in Europe. The manufacturer is reaping just $90 million annually from its sale. That's not much. Sarepta's Market Cap jumped more than ten times that amount today alone, to $2.66 billion.

Since Europe is a comparably sized market to the United States, I think SRPT is looking just a tad frothy.

Lastly, note that the FDA has still put a requirement on SRPT. It might not sound like much, but I'm sure it will be expensive. And what if the additional testing goes badly? Then there goes the stock.

Sooo, quite a bit of risk, and a less lucrative market than previously thought. It's a good idea to sell before others figure this out. 




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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:
Sarepta Wins FDA Nod For Embattled DMD Drug -- But With A Catch
By: Decomposed in POPE IV
Mon, 19 Sep 16 9:03 PM 		Msg. 11287 of 47202

September 19, 2016

Sarepta Wins FDA Nod For Embattled DMD Drug -- But With A Catch

Arlene Weintraub
finance.yahoo.com

Just five days after its main nemesis at the FDA departed the agency, Sarepta Therapeutics has won a long-sought-after approval for eteplirsen, its drug to treat Duchenne muscular dystrophy (DMD). It’s been a long, strange trip for the Cambridge, MA-based company, which has held strong support from the DMD community but endured everything from a freak snowstorm that delayed an FDA advisory committee review, to the aforementioned critic, Ron Farkas, who seemed to be doing everything in his power to prevent eteplirsen from getting approved. In a statement, the FDA said it is requiring Sarepta to perform another clinical trial to prove the drug does what the company claims—namely that it improves motor function in DMD patients who have a particular mutation in a gene that produces dystrophin, a protein key in proper muscle function.

http://finance.yahoo.com/m/4abc677a-b9c1-33ef-8eb8-9dbd14042c9f/ss_sarepta-wins-fda-nod-for.html

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