Will Sarepta Be Bought Out in 2013?

• Report this Comment On January 12, 2013, at 10:20 AM, MEDS4HEALTH wrote:

  Kimberly Lee, an analyst at Janney Montgomery Scott LLC says Sarepata probably won’t receive accelerated approval based on current results in so few patients and likely will be required to run a larger, pivotal study. I would like to present an alternative view. Sarepata is seeking results in a new area of drug therapy which is RNA based Orphan drugs used to treat rare diseases presently are DNA based.

  Several drugs on the market today such as Cerezyme for treatment of Gaucher’s disease, Fabrazyme for Fabry disease and Myozyme for Pompes disease come to mind. These drugs were given FDA approval based on very similar study groups to Sarepata’s eteplirsen.

  Eteplirsen has been proven to have little side effects in all patent’s receiving the medication. The positive results far out weigh the chances of adverse effects since Duchenne disease is fatal in most cases by 25 to 30 years of age. All of the above medications have side effects and often times present adverse effects that must be reported to the FDA. Myozyme even has a black box FDA warning to health care professionals.

  It is clear that Kimberly Lee has not sat with a child with one of these diseases and seen the terror in the eyes of a mother or father hoping for something positive to happen to save their child from a dreaded disease. Parents, physicians, pharmacists and nurses are joining advocacy groups to petition their congressional representatives to ask the FDA to fast tract eteplirsen. In the coming weeks and months, the pressure will build to approve the drug and than increase the sample size. At least more children can be treated while compiling more data. Also funds can be provided to Sarepata to implement full scale production.

  Let us depend on our financial analyst to recommend or not recommend stocks based on solid financial statements. In this case, let us look to medical research personal to look at medical data to conclude what the FDA may do or not do.

  I am long the stock

• Report this Comment On January 16, 2013, at 11:50 AM, NoPanicBill wrote:

  Talking heads do not belong in predicting FDA potential approvals. This type of commentary should come from qualified ex-FDA members or medical professionals. I don't need a potential weatherman or sports announcer to give me advice, because they are wrong most of the time. That is what you have here, an unqualified person reading from a script written by someone else. There is a proven potential for FDA approval for this medication to be fast tracked with a ongoing study to be performed concurrently with dispensation. That statement is a real fact. If the FDA does announce a fast track decision the possibility of a buyout at that time will increase expotentialy as most big pharm will make their move then. That can be proven by using past history of M&A's. I stand by my own DD and use quality information from outside sources. What was provided here was not.

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