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Sarepta Therapeutics, Inc. Message Board

simp08801 222 posts  |  Last Activity: Feb 28, 2015 2:46 PM Member since: Apr 10, 2000
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  • Reply to

    From Christine today

    by thigrlsrk Jan 27, 2015 5:09 AM
    simp08801 simp08801 Jan 27, 2015 9:58 AM Flag

    sounds like there was an uptick in the number of parents who decided to agree to the biop

    I continue to believe the 4th biop result is critical to the fda process, just like the d recount

    why?

    ambulatory benefit is now open to all kinds of debate (natural history moving targets, now even steroid beneifts short term, bla bla bla)

    but the restoration of a reliably measured amount of dystrophin, and what that can mean, especially when drug given at younger ages, is not open to nearly as much debate

    show me good recount and 4th biop results and IMO, this situation graduates from lottery ticket status to something that absolutely must be approved by FDA ASAP

    it might take 5 to 8 years to really know for sure what it does, but absent something better, the fda has to approve if d count is up and they accept the counts

    JMO

  • this is getting mildly interesting

    the institutional shorts in srpt had a great year

    but this drift up from 12.60 on 12/15 is surely not thrilling them

    the net short increased 140,000 shares in first 2 weeks of December, as I presume they successfully participated in the "under 13" push, which worked

    12/31 book marking means EVERYTHING

    the stock can leap 10 bucks on January 2 and it is not nearly as important, as they have a full year to recover

    but when there are only 20 hours of trading left in the year ... it matters

    14s is mildly annoying them off 12.60

    what if gri is right and srpt were to drop good news tomorrow or Wednesday?

    now that would REALLY cause a serious commotion in the short ranks

    ...

  • absent a negotiated patent settlement, the clinical fates of both drisa and etep will be determined years before any disputed patent issue between them is ever finally adjudicated

    you have to expect BioMarin management to whisper the patent issue in this instance

    and you have to expect stock jockeys, monkeys and lessor rodents to jump on it like its gospel

    its not

    it is now, as it has always been

    the fda will determine the ultimate flow of things here, both in terms of drug, and money

    srpt has a mountain to climb, and make no mistake, so does rna/biomarin

    impending srpt clinical data looms large (168 and dystrophin recount)

    much larger than patent noise at this juncture of the timeline

  • those short funds are surely #$%$ at the uptick from 12.60 to 15ish right at the end of the year

    could you imagine what would happen if the company dropped positive 168 week data with only a day of trading left in the year?

    now that would be spectacularly funny

    ...

  • simp08801 by simp08801 Dec 3, 2014 8:06 AM Flag

    what is your srpt priority list?

    here is mine, in order of priority:

    1. 168 week walk data (why? IMO, the continuing fad saga on dystrophin as a surrogate marker becomes moot, in reality, if the fda even gets a hint of no clinical efficacy)

    2. thrice confirmed (or not) dystrophin data: unless you are living under a rock on Uranus, it seems clear that the FDA is highly suspect of something about the srpt dystrophin data, so confirmation of such data via a process we now know was approved by fda is a very close second behind 1 above)

    3. staying on schedule in all ways, regarding all fda imposed NDA filing preconditions, for the mid 2015 NDA filing (this is now even more important now that RNA is spelled BioMarin … and accomplishing this seems harder than it appears, especially generating required safety data since the srpt dosing of new patients makes a snail look like it could win the Olympic 100 yard dash)

    4. 4th biop results (this is 4th only because the visibility on this outcome should be informed by 2 above (and IMO, results of 2 comes before results of 4

    5. actually finding a real person take srpt CSO job (the failure of the CEO to actually accomplish this to date is very troubling to this stock monkey, as it may signal his continuing thirst for sole power over everything, and worse)

    6. reading and categorizing your posts, for future use by all mankind

    as to timing, I think all bets are off on 1 and 2, as they could drop today, or two months from today (I hope sooner than later)

  • Here is exactly what AF said when nominating RNA CEO:

    Hans Schikan, Prosensa

    Let's compare two chief executives, both running companies developing new drugs to treat Duchenne muscular dystrophy, a rare, muscle-wasting disease. One CEO is gregarious in public, eager to court the support of patients and their families. He's a bit promotional and prone to making big promises. If he angers or offends anyone, it's only because he's working so hard to cross the finish line.

    The other CEO is quiet, reserved. He cares just as deeply about patients and their families, but is also worried about making promises he can't deliver. He'd rather work behind the scenes to advance his company's goals instead of negotiating in public. Politeness is a virtue.

    Who's been more effective in developing a new DMD drug so far? The first CEO's gabby nature and penchant for promise-making appears to give him the edge. Only later do we find out the CEO's feel-good story is a facade covering up fractious corporate infighting, poor decision-making and alienation of regulatory authorities. Patients and investors are punished.

    Meanwhile, the second CEO deals diligently with setbacks, working to extricate his company from a foundering Big Pharma partnership in a position to still achieve its goals. He listens to regulatory authorities and quietly builds a case to support his drug's approval. There's nothing flashy about his approach, but it's effective. When the first CEO blows up and his drug is delayed, the second CEO is still standing. His company will be the first to submit for regulatory approval of a DMD drug.

    And in the second CEO's "spare" time, he sells his company for $840 million, rewarding shareholders for their patience and bringing in a more experienced partner to increase the odds his drug is approved.

    Congratulations, Prosensa's Hans Schikan. Your nomination for Best Biotech CEO of 2014 is well-deserved.

    NOW THAT IS SOME CHARACTER ASSASINATION ...

  • new AF article is good example of how sprt worm has turned, for the moment

    AF actually uses words that clearly imply that BioMarin had a choice BETWEEN rna and srpt and chose rna

    he is correct, in that BioMarin did choose to buy rna

    but there was NO opportunity to buy srpt, none, nada, zilch

    there was NO choice regarding srpt

    and he knows that, or at least should know that

    clearly, he did not check with srpt on this issue

    very good example of the negative vibe surrounding srpt at this time

    this vibe will not fix itself

    impending data looms

    PS to devil: pleez ask star to check around on staffing issues, cuz although me and my friend johnny87778 both think np is a dooooosh, we must check on every lead we get

  • simp08801 by simp08801 Jan 5, 2015 12:38 PM Flag

    seems to me that the impending 168 wk data and dystrophin recount BY the company, are literally binary

    I say this because the 144 wk data was generally viewed as slightly noisy vs. the 120 wk data, thus introducing even the smallest spek of ship in the milkshake

    after the 144 wk data, the milkshake looked tasty, and even was tasty, but the knowing of that tiny teeny spek of ship was in there was largely responsible for the 50% market cap adjustment of the last several months

    if the 168wk data and dystrophin recount can extract that spek, then perhaps the market will assume that even a whacked management cannot stop the drug

    we need the data

  • simp08801 by simp08801 Jan 15, 2015 4:41 PM Flag

    in reviewing all the CEO's words, it now appears to me that "mid 2015 now means sometime in July or perhaps August

    I am not going to say it ...

  • simp08801 by simp08801 Feb 23, 2015 4:53 PM Flag

    money is possibly God's greatest "objectivity destroyer"

    IMO, if you are able to somehow extract the word "money" from your brain, I assume you would readily agree that the irrefutable very best thing for the dmd community would be for a large pharma to take over for srpt,'s dmd efforts via either partnership or buyout

    (ask yourself this: where do you think the srpt dmd effort would be right now if a large pharma had either purchased or partnered with srpt 30 months ago? ...)

  • "all boys still walking"

    168 week data looms large

    ...

  • Reply to

    Anyone Notice?

    by faithdan511 Dec 10, 2014 12:51 PM
    simp08801 simp08801 Dec 10, 2014 12:54 PM Flag

    FWIW, I read it exact same way

  • impressive:

    11 boys in 4th biop

    that is incredible beyond words and lends such credibility to the results (good or bad ...)

    it appears the only boy out was the one with previous general anesthesia issues

    disappointing:

    no hep c update to follow on to yesterday's ebola update

    radio silence could be here for a while pending pre nda meeting

  • I am trying to find an available professional football stadium

    we need a group hug

    plus a team picture with all the duncers (wide angle required)

    also, nekkid will unveil two things at the event: (1) 4.75 price target, and (2) the next phone

    I will update on the Visa litigation and why I support nekkid on wanting to landfill Richard's MG

  • simp08801 simp08801 Jan 12, 2015 5:01 PM Flag

    gri

    heads up

    srpt is continuing with missed deadlines

    the latest being the 4th biop

    THEY WERE SUPPOSED TO BE DONE IN DECEMBER

    they are now just be scheduled

    do not listen to those who tell you they are on schedule, cuz they aint

    FDA wants that data for the NDA submission

    the company continues to miss timelines that threaten the filing

  • Reply to

    Not a good sign....

    by w.jim43 Feb 3, 2015 9:54 AM
    simp08801 simp08801 Feb 3, 2015 10:07 AM Flag

    this is not good news

    but it is also news that any investor not in a coma should already be aware of

    the company's market cap has been decimated in the last 6 months

    its called increasing/material investor apprehension/doubt

    I am actually surprised the IV total did not drop more!

    IMO, the market is not always right, but is right more than it is wrong

    the story here should have finally unfolded over the next 6-12 months

    but in the meantime, increasing investor doubt (and resultant market cap reduction) has dominated the trade the last several months

  • in testing to date, drug has moderately less efficacy than at least 4 other compounds

    drug is materially more expensive to make than other 4 compounds

    drug delivery more complicated than other 4 compounds

    largest ebola outbreak in modern history, srpt repeatedly advises all concerned it has a certain limited drug supply available, and the drug is not administered to a single ebola patient

    in prior years, fed gov made multi-million investment in srpt ebola drug, but ceased program (choose whatever reason you want to espouse, end result the same)

    this does not mean that srpt cannot in the future potentially garner a much higher market cap off certain of its other drug candidates

    but IMO, you should definitely scratch ebola off the wish list

  • the weaker trade on mildish volume is not, per se, about anything new that was said on the earnings call

    rather, it was the fact that today's call did not in any way mollify the concerns raised by the things the CEO said on the RBC call earlier this week

    WARNING

    if you disagree in any way with anything I have said in this posting, then YOU ARE DEAD TO ME

  • he said last night on BNN that he believes Nept is a 7 or 8 bagger from here

  • you see it all around you

    1. the other day, BioMarin exec's talk of possibly enforcing their US IP rights they allege they have (surrrrrrrrrrrrrre, but it works real well in terms of posture)

    2. one day after the srpt dmd community update, first thing in am BioMarin CEO uses words which clearly are intended to suggest that it "chose" to buy RNA over Srpt (giving impression it had a choice of either and chose RNA)

    3. now, BioMarin CEO is on fastmoney today at 5pm

    this gamesmanship will continue as long as clinical and fda directional vagaries continue

    once you have clinical and fda clarity, it will cease ipso facto

    but for now, its the wild west

SRPT
13.90+0.08(+0.58%)Feb 27 4:00 PMEST

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