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Sarepta Therapeutics, Inc. Message Board

  • zwerp2000 zwerp2000 Jul 4, 2013 9:11 AM Flag

    If we presume SRPT does not know what the FDA is going to do then......

    The ATM may simply be a hedge. Instead of setting a price which of course shorts would argue says no AA because why would they set a price at these levels when AA is coming and the price will be much higher?? So, presuming the company does not know what the FDA will do, set up an ATM were you raise a little money now and then if the FDA says to file for AA, the stock will be higher and that will be less dilution.

    I really don't know what the company knows. We can look for any signs at this point such as filing for an ATM but not setting a price (bullish imo), recently leasing a huge space (bullish) and ppmd meeting with the FDA for the 6th or 7th time (bullish). Keep in mind though, if you read through the recent wells fargo transcript on June 19th, some of the things we have been seeing are in line with what chris says:
    "So we don't believe there is a benefit for a higher dose here beyond 30 mgs per kg in terms of producing more dystrophin."
    "...And again the Eteplirsen program status, we are trying to finalize a tentative date now that we have that would occur with the FDA to discuss this accelerated approval issue by the end of July. We don't have that confirm date, but we're hopeful that this tentative date will come through that would occur by the end of July and we expect that that meeting, they'll have reviewed the two documents we submitted one on dystrophin, one on clinical outcomes to be able to make their recommendation or guidance for us on whether or not a accelerated approval NDA that we would submit will be accepted for filing.
    As we stated previously, based on that guidance if we do pursue accelerated approval, we want to meet with them hopefully by the end of the third quarter to discuss CMC. And what will need to be in the CMC section to be accepted for filing as well. And then we'll have better guidance on the timing of the potential NDA if the FDA's support of an accelerated approval filing.

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    • We're still on track to prepare for our confirmatory clinical study. We are expecting dosing to start first quarter. We're scaling up manufacturing, this is a case where no news is good news, because as soon as we have a hick up of anything that would delay that, we would conclude that we can't start dosing confirmatory study, but now we're on-track. We still expect to start dosing of our confirmatory study in the first quarter and we've started the beginning stages of large scale production not because we have got a signal on accelerated approval, but we think it's the smart thing to do to start to prepare for larger scale up in the event that we do get in the odd and have to start thinking about commercialization even as early as the second half of next year. "

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