Depends on how bad the information is about Kynmaro. Right now, it looks like AEGR is on track for approval already by the EMA.
Your financial analysis is sound, the only question is the time frame. That is why it isn't over $1,000 yet, because of the timing. Once they start realizing substantial revenues, you'll see a major spike up in the share price.
Actually the EU approval will be another month or so after the CHMPs recommendation.
I don't have the figures on how many patients from last quarter were paying, but the patient count is definitely in the rise. The fact that they have identified a wider patient base is very encouraging. They will likely increase their base even more next quarter.
The real question is how long to achieve meaningful market penetration? Will they get 10% of the US market (300 patients) next quarter?
I wonder what Adam's excuse will be as the revenues pour in each quarter. This quarters earnings beat is just the first of many.
So what. Nobody cares. The drug works. That's all that matters.
Yes, yes, yes. No profit, no revenue, no cash. You should continue to short again and again like all those who started shorting at $15. You'll make it up on volume.
Yes, no ports, no revenue, you must short more. You must short more.
No EU CHMP approval coming in the next month. No dramatic increase in patients. No spike in revenue. No significant beat in earnings coming Tuesday. You should short more and more.
How DARE you isolate one single mistake by Jim Cramer when there are literally thousands of mistakes by Cramer out there to choose from. Then again, it wasn't really a mistake was it? Corruption and market manipulation are a whole different game.
The only reason the FDA is asking for this information is because AA and approval are imminent. If the FDA wasn't going to grant AA/approval, then there would be absolutely no need to request this additional data. They would have simply said that there wasn't enough information to grant AA, or the trial size was too small, or something else.
The AA will happen imminently, and approval will too, both in 2013.
The FDA is asking for dystrophin as a surrogate endpoing, because the GSK drug doesn't do it and this will directly support AA and rapid approval of eteplirsen. Faster than anybody expects. Watch it happen in 2013.
You are correct in every regard. The FDA is signaling that they intend to approve NOW. It will happen in 2013.
Not even close. If that were the case, then the FDA would not have asked for written summaries supporting the use of dystrophin as a surrogate endpoint for approval, as well as a discussion of clinical outcomes from the phase II study. The reason the FDA is asking for this data is because they are preparing for approval and need all the supporting data to make it an approval in accordance with their rules and regulations.
Adam is correct:
The U.S. Food and Drug Administration is actively reviewing the efficacy and safety of Sarepta Therapeutics' (SRPT) Duchenne muscular dystrophy drug eteplirsen even though the drug has not been formally filed for approval yet.
Weird, huh? But also good news for Sarepta. While investors have been obsessing over whether or not FDA will allow an eteplirsen accelerated approval, the agency is already reviewing the drug as if it was filed.
Why? Because FDA understands that a decision to allow Sarepta to file for accelerated approval filing means eteplirsen will be approved. What's going on with eteplirsen now at FDA is not a "file or don't file" decision, it's a mini review.
Read carefully Sarepta's announcement Monday because the evidence of an ongoing eteplirsen review is all there. FDA has asked the company to provide written summaries supporting the use of dystrophin as a surrogate endpoint for approval, as well as a discussion of clinical outcomes from the phase II study.
The FDA doesn't ask for this type of information from companies who haven't yet filed a drug for approval. Instead, these are the types of questions FDA asks of a drug sponsor during the review process.
** Bottom line: The FDA is lining up the data they need to support the approval and the full approval will happen faster than anybody expects **.