No I don't think that is what it means. What this means is that the 48 week IHCs (biopsy specimens) have to be reviewed by a panel of expert pathologists not one person (or multiple persons independently). This is a standard procedure in evaluating biopsy specimens when inter-reader agreement is expected to be very high. We once did a similar study for borderline lesions and the kappa for nine expert pathologists came as around 0.4. This was not even a panel. It was an independent evaluation. Now FDA is asking evaluation by a panel of experts, which is good because it means FDA is also willing to look at IHC results in addition to WB.
Don't be surprised if they had done the same for 13 promovi kids. Even though the PR released a couple of weeks ago only mentioned about WB it is possible that SRPT submitted IHCs before WB and FDA asked for WB as confirmation.
True but they are counting on the statement from the SRPT PR that said "over the coming weeks". They are betting that it will not be this week.
A month later they announced 48 week results, which showed statistically significant improvement. Stock price went to $45. They did eventually raise the $40M in the next couple of months but average share price was much higher than the price the day ATM was announced.
You are wrong. You have no idea what an ATM offering is. We will not know how many shares are purchased and at what price until the next CC.
September 4, 2012.
For those of you newbees this is one month before SRPT announced ETEP 48 week news and stock shoot up 200% on the same day. Back then the price was around $15-$16/share.
Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-based therapeutics, entered into an At-the-Market (ATM) equity offering sales agreement with Citadel Securities LLC on September 4, 2012, under which Sarepta may, from time to time, offer and sell shares of its common stock having an aggregate value of up to $40 million through Citadel. Sarepta expects to use any proceeds from this offering for general corporate purposes, including the continued development of eteplirsen and other product candidates.
June 8, 2016 (Today)
Sarepta Therapeutics, Inc. (SRPT), a developer of innovative RNA-targeted therapeutics, today announced that Sarepta, through Credit Suisse and Robert W. Baird & Co., intends to sell an amount of its common stock equal to approximately $37.5 million in gross proceeds in an underwritten offering, before deducting underwriting discounts and commission and other estimated offering expenses. Credit Suisse and Robert W. Baird & Co. are acting as joint book-running managers of the proposed offering. The underwriters propose to offer the shares of common stock from time to time to purchasers directly or through agents, or through brokers in brokerage transactions on the Nasdaq Global Select Market, or to dealers in negotiated transactions or in a combination of such methods of sale, at a fixed price or prices, which may be changed, or at market prices prevailing at the time of sale, at prices related to such prevailing market prices or at negotiated prices.
Please do some research. Don't be lazy. You are asking an obvious question which has been discussed here on multiple posts yesterday and the day before. The company has the biopsy samples but these samples have to be interpreted by a third party. That is why it will take a few weeks to get the results.
Now I get it. They already know baseline WB is essentially at zero for all thirteen patients. The bar is set very low. Given that some of the patients in the Promovi trial already testified in ADCOM as benefiting from the drug I don't see any reason why at least half of the thirteen patients don't show increasing dystrophin levels at 48 weeks.
He says other interesting things in his blog. I didn't know that SRPT released baseline WB measurements from some of the Promovi patients.
"But it's entirely logical and likely that FDA will be satisfied with eteplirsen dystrophin production which approximates and confirms the 0.9% of normal seen in the prior study."
"We've already seen baseline dystrophin production data from some Promovi patients at essentially zero -- in line with patients enrolled in Sarepta's phase II study."
I didn't know that SRPT released baseline WB measurements from some of the Promovi patients.
"I've read some bearish analyst reports this morning which claim FDA will need dystrophin expression of 10% of normal or more in order to approve eteplirsen. Frankly, that's absurd."
Agreed but I don't think FDA is any more concerned about correlating dystrophin with 6mwt at this point. If they see consistent increase in dystrophin measured by WB at 48 weeks compared to the baseline they will approve it.
I agree. Yesterday's PR was very important. It is the first official sign that FDA is now seriously considering of granting SRPT AA. $20.2 after hour price is a joke. We will see $25+ tomorrow and $30+ in 3 days imo. I am adding first thing (7am) tomorrow. I am selling two of my holdings to buy at least 2500 shares of SRPT tomorrow premarket. I will also increase my holdings in my 401K.
It is similar to what? The existing WB data from 12 boys didn't have the WB baseline. This will be the first time we will have both WB at baseline and at 48 weeks. This is a very important piece of data. If we can see that WB increased from baseline to 48 weeks for at least 5 of the kids and remained more or less same for the remaining ones AA will come for sure even if the increase is not statistically significant compared to the baseline.
True but the question is when were they obtained. Last week, two weeks ago, or three months ago? It makes a huge difference for reading the tea leaves.
Does anybody know when the 48 week WB data became available for the confirmatory trial? The date will tell us if this news is bullish or just neutral.
If this data became available before ADCOM and the company didn't mention about it then I will take that as "inconclusive evidence". However if the data became available (at least for most of the 13 kids) after the ADCOM then we might have new favorable evidence that may finally convince FDA to grant AA.
Anyone wants to chime in?
$100+ is possible with AA. It may later settle down to $50-$70 range but short squeeze may take this to over $100 in the three days following AA.
The probability of approval will increase after each day with no news from FDA. I had 9500 shares but I sold 4500 of them on Thursday for a loss. I hope we don't hear from FDA until my wash sale period ends so that I can buy back those shares before the approval is announced. If no news until July then AA would be almost certain IMO.