Recent

% | $
Quotes you view appear here for quick access.

Sarepta Therapeutics, Inc. Message Board

specman4 22 posts  |  Last Activity: Feb 5, 2016 2:41 PM Member since: Oct 20, 2009
SortNewest  |  Oldest  |  Highest Rated Expand all messages
  • Reply to

    Chicken Out

    by gigilasky Nov 19, 2015 2:22 PM
    specman4 specman4 Nov 19, 2015 3:42 PM Flag

    Just shaking the trees. Some traders just play the run-up and bail before the event. Everyone is worried about the small number of kids in the P2. No worries! The company is requesting AA. The AA can be granted on a smaller P2 trial with meaningful drug effect and safety. The AA will be conditional and will require a "confirmatory trial" or P3 trial to secure a full approval in the coming 12-18 months. Only the company poised with a confirmatory trial underway and enrolling will truly come out of these meetings with a win.

    Sentiment: Strong Buy

  • specman4 specman4 Nov 20, 2015 8:08 AM Flag

    Based on the need and the possibility to design a confirmatory P3 trial that can demonstrate that possible benefit... They still need to design and enroll that trial to secure the AA. Of course, the confirmatory trial has to produce meaningful benefit and acceptable safety to warrant a full approval. I now love the etep horse even better.

    Sentiment: Buy

  • Reply to

    Big Props to bionerd51

    by mdwhittier Nov 20, 2015 6:38 PM
    specman4 specman4 Nov 20, 2015 11:05 PM Flag

    Ditto. Shout out to Hard Focus for the same. Long ride, but a ways to go.

    Sentiment: Strong Buy

  • specman4 specman4 Nov 20, 2015 11:13 PM Flag

    Agreed. But... What if, they granted AA shortly after next Tuesday and before the normal 55 day lock-in for the Ad Comm meeting. Really optimistic, YES. However, after they debate the drisap data to pieces and ask themselves the big question... What is left to debate? A confirmatory trial will be required and they clearly know the etep data by now.

    Sentiment: Strong Buy

  • Reply to

    Buyout Company is...

    by prb6002 Nov 21, 2015 9:48 AM
    specman4 specman4 Nov 23, 2015 8:45 AM Flag

    Agreed. Gilead understands the value that a hot new platform can add to their own market cap. ie. Their 10B investment in HepC a few years back. This acquisition was said to be too rich at the time, but look at the revenues now and their stock doubled and split and tripled from there... I think there will be others in the talks. As a Gilead shareholder, I hope they win. Target: $105-$120

    Sentiment: Strong Buy

  • Reply to

    Barron's Bottom Line

    by mdwhittier Nov 21, 2015 11:48 AM
    specman4 specman4 Nov 23, 2015 5:14 PM Flag

    Have not seen that name in a long time. You've been around a while to drop that name. I doubt the great prognosticator could have predicted the roller coaster ride that we've experienced. Great to see the leadership and the FDA behaving well.

    Sentiment: Strong Buy

  • Reply to

    what do you think bmrn ceo is praying for?

    by simp08801 Nov 24, 2015 6:04 PM
    specman4 specman4 Nov 24, 2015 6:08 PM Flag

    He should be getting out of the way and praying for a 12% royalty on etep in the EU. That's the only way he recoups his $800M. Of course, their grandstanding with the drug hope moved their market cap up nicely. ($75 - $150 - $95 - ???. Going away soon.

    Sentiment: Strong Buy

  • Reply to

    PT for Sarepta after FDA aproval

    by navidnamini Dec 2, 2015 1:38 PM
    specman4 specman4 Dec 2, 2015 9:37 PM Flag

    Best guess... $60-$70 on a spike. The analyst will mostly support these levels, but it will retreat a little while we all wait on execution and revenue. The revenue ramp should go well, but will likely fall short of the Street's expectations. All of that won't matter. Some Pharma will come calling before they hit their stride and take the enterprise. It should be worth 3.5 - 4.5 billion. ($75-$100 pps) Of course, if they actually drive revenues to the 500-700M level (US) and the pathway for the follow-on exons is clear... $200+ becomes a reality. Any EU pathway changes this greatly.

    Sentiment: Strong Buy

  • specman4 specman4 Dec 18, 2015 9:51 AM Flag

    I believe the FDA has delayed their decision to minimize the blow-back from BMRN and the advocates. It still seems likely that they will require a redesigned confirmatory trial before BMRN gets approved. SRPT has already started that trial under close watch of the agency. Expect etep to be approved after their advisory committee. Their confirmatory trial will solidify and expand their label in early 2017.

    Sentiment: Buy

  • I can't recall when this type of after-hours volume presented. Nice and controlled flow to hold the price in a tight range. Someone just took notice in a major way.

    Sentiment: Strong Buy

  • specman4 specman4 Dec 18, 2015 6:03 PM Flag

    I keep waiting on one of Gary's predictions to really hit big. He has called a few catalysts right over the years, but like most of us... Just drunk on the AVII Koolaid. We do deserve a great Christmas and a Happy New Year.

    Sentiment: Strong Buy

  • Reply to

    Crazy after-market volume...

    by specman4 Dec 18, 2015 6:00 PM
    specman4 specman4 Dec 18, 2015 6:11 PM Flag

    It's that 3rd Friday thing... Likely so. That's still a high number. I don't recall it reaching that high before. Wouldn't the options clear before 4:00pm? Admittedly, I'm not an option guy.

    Sentiment: Strong Buy

  • Reply to

    Who Plans To Sell

    by hernzd Jan 6, 2016 10:13 AM
    specman4 specman4 Jan 6, 2016 11:40 AM Flag

    If it has good trajectory through the 50's it will likely settle higher. Maybe $60-72. That level may not hold long, but would present a tough decision. I suspect a deal price would land north of $85 and could go much higher if BMRN is out of the picture or delayed. After nearly 7 years of holding most of my shares, another 4 months seems trivial. Greater values ahead!

    Sentiment: Hold

  • Negative news coming for BMRN, positive data on the SRPT confirmatory trial, tough questions with clear answers in the briefing documents, Advisory Committee will make the link and see benefits, conditional AA will be granted on existing data with a future review of the confirmatory trial for validation. What will the pps do? Time will tell. I predict a strong commercial launch based on the fact that SRPT already has a well populated register of patients including exon 51 and beyond. (The best thing CG did during his term.) Boys on drug in Q2! That what matters most.

    Sentiment: Hold

  • Reply to

    Pfizer eyeing SRPT?

    by hardfocus Jan 13, 2016 9:21 PM
    specman4 specman4 Jan 14, 2016 8:15 AM Flag

    Pfizer has been preparing for its entry into the rare disease space for years. The have an office right down the street in Cambridge and the fit is perfect. Expect them to be at the table, but others will show.

    Sentiment: Hold

  • Although the Ad Comm will not be a cake-walk, these drugs have very different chemical backbones. Both were designed to elevate dystrophin. Drisap would likely do just that, if it could be dosed higher. The side-effect profile does not allow the dosing to get to the needed levels. Etep does not have the same side chain and therefore can be dosed much higher. Decide for yourself, what you believe. Good luck!

    Sentiment: Strong Buy

  • specman4 specman4 Jan 14, 2016 2:19 PM Flag

    Bionerd is correct. Although the term "conditional approval" may not be found in FDA land, the AA is essentially just that. The AA would grant SRPT the right to market etep based on their Phase 2 data on safety, efficacy, and or surrogate endpoints. The full approval would follow when the "confirmatory trial" reads out. That trial was started last summer and will likely read out safety data soon. Remember that... No real efficacy is expected at 24 weeks. For any new folks, IMHO, Bionerd is always on target.

    Sentiment: Strong Buy

  • Reply to

    When we hit $131.00

    by qpoint617 Jan 14, 2016 7:34 PM
    specman4 specman4 Jan 14, 2016 9:43 PM Flag

    It can still be a little cold on the Cape in March... Just saying. I'm in.

    Sentiment: Hold

  • Reply to

    The FDA's Blackeye..

    by bionerd51 Jan 18, 2016 8:41 PM
    specman4 specman4 Jan 19, 2016 10:15 AM Flag

    Correct. I understand your frustration and feel your pain. "It's not over until the 27+ BMI lady sings". Many believe she is warming up back stage... I say this: 1) I have never seen a positive set of briefing documents. (after 25 years in this business) 2) Given the political pressure to be equally tough on both applicants, they needed to drill into the possible weak points. 3) The FDA will often take a contrary position on selected data points to facilitate discussion and debate. They need to know that the applicant can make the case for their own data. Interesting and perhaps tough days ahead. The big question... How do we feel Friday night?

    Sentiment: Hold

  • Reply to

    The FDA's Blackeye..

    by bionerd51 Jan 18, 2016 8:41 PM
    specman4 specman4 Jan 19, 2016 11:40 AM Flag

    As stated too many times... This trial was not intended to be a final trial. The results do warrant serious consideration and may justify AA. The final confirmatory trial started last summer. This trial has the numbers and design to prove all points and validate the AA this could be coming soon.

    Sentiment: Hold

SRPT
11.71+0.42(+3.72%)12:40 PMEST