It is never wrong/a bad idea - to take profits & pull your original investment out. Take a look at where SRPT is now, what its potential is, what the risks are, and ask yourself - would I buy it here/now/today if I didn't already own it. If the answer is yes, then you shouldn't sell it.
The FDA accepting and filing the NDA was not a done deal, nor was it widely expected, as one article errantly reports. It was definitely widely hoped for, but given the problems that Sarepta has had with the FDA in the past, NDA acceptance/filing was by no means a done deal until the FDA officially accepted it, as they did yesterday.
It is an outstanding confirmatory step in the relationship between the FDA and Sarepta, which was rocky for a very long time. This acceptance & filing represents concrete proof that hints are ironed out, and hopefully will lead to approval of Eteplirsen.
I am personally very glad they got it done. I feared the headline would come in as an RTF letter instead, but thankfully, that didn't happen. Now that they have gotten past this major obstacle, all lights go green for approval since they have the efficacy and safety profile that are overwhelmingly positive. The thing holding back SRPT in the past was the regulatory hurdles, which they seem to have now cleared. Now that real progress is being made, I am very optimistic for a favorable Adcom vote in November, followed by approval shortly thereafter.
You may be right, but the chance of getting an RTF was a very real possibility. One that weighed heavily on the stock. Pick your reason, small trial size, problems with the FDA interaction (which now seem cleared up) or whatever, everything seems to be on track now.
This risk reduction should be reflected in the stock and shares should surge. The end target of $100+ remains. The only question is when will shares reflect that valuation? Will they reflect it incrementally as risk factors like this are eliminated, or all at once upon Adcom favorable vote?
I view the formal acceptance of the NDA by the FDA and filing for Eteplirsen as a major hurdle crossed especially in light of repeated failures in the past where they couldn't even get the FDA to accept the information let alone actually file the NDA.
This represents a major improvement and increased value of SRPT as it moves towards November's Adcom and eventual (hopefully) approval. The value will be realized in the stock as the market determines, but my "Net Present Valuation" model nets it at $65 right now and over $100 on Adcom favorable vote.
I'm a cheap SoB and wanted to buy cheaper. Oh well, if the big pop up comes on Wednesday as Piper predicted, today's drop will be at the noise level anyway.
Very old and outdated news. This was resolved a long time ago. SRPT was chastised for the small trial size but the efficacy and safety cannot be refuted. Sarepta has done their penance through several delays in accepting the filing with the NDA, has launched the requisite confirmatory studies and everything is aligned for acceptance next week and Adcom before Thanksgiving.
It is as if you are a short seller trying to rehash old news because that is all you have.
Are you going to challenge Hillary's presidential run due to the Monica Lewinsky impeachment?
They aren't idiots, many sell because they are removing "at risk" money. Think about it, if you are a fund manager and you want to sell 5% of your holdings of each of your stocks to move to a larger cash position, you could potentially sell 5% of each and every holding you have, just as a defensive measure. Remember that most funds have to maintain no more than 2% of any one security, so if they sell one, they have to maintain the balance, and have to sell some SRPT - not because there is anything wrong with SRPT - but because they will end up with 5% SRPT because they are selling other things, creating an imbalance.
Everything about SRPT remains in tact and today's selling is nothing more than being part of an overall market drawdown.
Yes. The FDA has 60 days to either accept or refuse to file (RTF) so based on a 6/29/2015 filing, that should project forward to 8/28/2015. So we should hear next week.
Looking at this morning's buyout of Sprout Pharma just after their FDA approval reminds us that M&A is very active in the BioPharma space. Looking at SCMPs balance sheet and revenues and it is clear that SCMP will be gobbled up within a year.
Sprout Pharma got bought out today, right after getting FDA approval for their drug to treat female sexual dysfunction. The only way this buyout could happen so quickly after FDA approval is if was pre negotiated ahead of time, contingent on FDA approval. The same scenario could easily prove to be true for SRPT. They could have the buyout already in place, contingent on FDA approval.
I hope not, because they will realize a much higher share value waiting for sales to come in, but something tells me the buyout is already negotiated.
Insiders haven't made any sales for almost 2 years. Only acquisitions, showing that management is confident it is going to go higher. Much higher.
Inevitably. The only queues toons are when, and for how much. A potential suitor should wait for approval of Eteplirsen so as to not rock the boat with the FDA, while having the reduced risk of approval before the buyout.
It would not surprise me one bit if they were already negotiating the terms and timing of the buyout right now, to be announced after approval.
It doesn't mean anything. If there are major problems the FDA usually won't let the company file to begin with (as we have seen previously with SRPT when they told them not to even try). Once the company is in lock step with the FDA and have given them all the data elements the FDA needs, then it usually runs smoothly, the NDA is accepted, and they go to Adcom where almost anything can happen on a drug like Drisapersen (meaning, it might get approved) - yet with drugs like Eteplirsen that are shown definitively to have the efficacy and safety profile, it should be a very favorable Adcom vote.
It still all has to happen, and according to the FDA time frame, otherwise the FDA would appear to be playing favorites. So be patient as some very good things are coming.
Watch for it - it is coming.
From the broad based strokes - the total available market (TAM) is about 15,000 boys in the U.S. and calculating it at $400K/patient (per Forbes & TheStreet, that puts the annual value of Eteplirsen at about $6B. That is a monster number (and nobody is pretending anybody will ever get 100% market share, but patients have no other choice). It will be reached much faster than many other meds, since this really is the only effective treatment.
Exons 53 & 45 could triple the potential value of Eteplirsen. So the real question is what is the total available market? While you can argue that Eteplirsen could target 30,000 boys worldwide, that isn't realistic, so we have to just look at the USA. We can argue $300K vs. $400K/patient, but apparently insurance companies have already agreed to numbers in that range, so that helps as well.
I estimate $100/share @ Adcom approval before Thanksgiving 2015, $175/share by mid-year 2016 (by July1) and $300/share by year end 2016. I do think that will plateau at that point and possibly pull back, but not until we cross the $300 threshold. So I'd have sell orders in at that point - because Eteplirsen sales will likely be stabilizing and will need another catalyst (good news on exon 53 or 45) to propel it higher.
Mark this post. Once approved and sales start flowing, Eteplirsen will have a very nice run to more than $300/share based on actual sales and sales growth, before topping out when sales hit peak based on percentage of patient population.