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msmorrisine 1579 posts  |  Last Activity: Jul 7, 2016 7:33 PM Member since: Sep 26, 1999
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  • Reply to

    An ethical question

    by thigrlsrk Jul 7, 2016 9:29 AM
    msmorrisine msmorrisine Jul 7, 2016 7:33 PM Flag

    You have to probe the question to get to the answer.

    It would imply 99% of the time Exon skipping does not work but 1% of the time it does Exon skip?


    It Exon skips 100% of the time, but for 1% of the time the effects produced were successful?

    I do not see a way for 1% Exon skipping success to be possible. I think you'll agree.
    As for the case of 100% success with Exon skipping but only 1% benefitted from the levels produced, then I question if that is possible. Such a wide variation for this specific of a molecular method?

    Outside the realm of Exon skipping and let's just say it's a magic synthetic dystrophin replacement therapy. Yeah, I think most people would vote for approval, including me.

    Sentiment: Strong Sell

  • And see what happens

    Sentiment: Strong Sell

  • Why was I saying the same thing over and over?

    Because I wasn't lying & and the point needed to be driven home.

    If in Oct/Nov 2013 Sarepta had listened to the FDA and provided better testing over the last 27 months the Adcomm results may have been for unanimous approval -- assuming the anecdotal stories from the parents are true.

    It all comes down to does the test data PROVE what the parents are saying.

    I'd like to believe the parents. Apparently the FDA is giving Sarepta yet another shot at proving it . Truly a good day for the parents and a somewhat good day for science (it'd be a great day for science had Sarepta double blinded, but again Sarepta need to do a lot of things differently).

    Congratulations parents and kids. No nod to Sarepta since things should have been different from them for years.

    The "hold" sentiment is not for the stock, but holding out hope the kids perform as well as parents say and this drug actually works.

    Sentiment: Hold

  • msmorrisine msmorrisine Jun 3, 2016 8:50 PM Flag

    Who, perhaps, were moved by the testimony of the parents and kids.

    But, again, showing it in a properly conducted test is another thing. And that was inconveniently not done by Sarepta.

    Now we are into approvals based upon individual pleadings.

    Not very scientific.

    I can't imagine anyone at Sarepta NOT knowing the scientific method..... now why would scientists not want to use scientifically generated proof?

    Mind Boggling. Problematic.

    Sentiment: Strong Sell

  • msmorrisine msmorrisine Jun 3, 2016 8:47 PM Flag

    You're right

    It was convincing 27 months ago when the FDA approved them then, and it was just so convincing that the AdCom approved it.

    What was swaying the people was the lobbying by the parents saying that it works.

    What kept this from being approved on May 27 was the testing data was unconvincing.

    Unless you wish to claim the testing data has them convinced and the delay beyond the 27th is for some special reason you'll tell us about.

    And I would have strong buy had Sarepta tested them properly starting Oct/Nov 2013 and the data showed the kids we so much more mobile. But Sarepta chose not to show mobilitiy testing numbers from a test that clearly demonstrates the claims.


    Tell me why.

    Sentiment: Strong Sell

  • msmorrisine msmorrisine Jun 3, 2016 8:41 PM Flag

    Unless you want to start expousing conspiracy theories, notice that you are quoting from a retracted story and note that it was retracted for a reason.

    Perhaps that story did not represent things properly.....

    Sentiment: Strong Sell

  • msmorrisine msmorrisine Jun 3, 2016 5:28 PM Flag

    not much out there on him except he was once covering Foreign Exchange and once covered Emerging Markets.

    Interesting place to hang one's hat on a drug trial. I don't suppose he conducted the trials?

    Sentiment: Strong Sell

  • Reply to

    From Billionaire to $0 & Sarepta

    by msmorrisine Jun 3, 2016 3:08 PM
    msmorrisine msmorrisine Jun 3, 2016 4:59 PM Flag

    lying about what?

    the FDA's AdCom actually DID vote for approval?
    The FDA's AdCom actually LOVED the testing results?

    *Make A Test To Prove *"Kids are running"*

    That's all that had to be done starting Oct/Nov 2013 (27+ months ago) and that's all that needs to be done now.

    Sentiment: Strong Sell

  • msmorrisine msmorrisine Jun 3, 2016 4:09 PM Flag

    If the FDA approves this, then they may as well pre-approved the other two pending safety data.

    but therein lies the problem.

    The FDA isn't really sure this works. They seem to be like me. They'd like to believe the parents, but the testing data is unconvincing.

    Sarepta could get away with the same low effort testing on further submissions if they approved eteplirsen here..

    And the FDA would be left with doubts about 3 drugs efficacy instead of one.

    I vote proper scientific testing regimes and making Sarepta do a new and proper controlled set of studies. so, no out right rejecting, but no outright approval either.

    Sentiment: Strong Sell

  • msmorrisine msmorrisine Jun 3, 2016 3:56 PM Flag

    Andrew Bary is an associate editor at Barron’s, The Dow Jones Business and Financial Weekly. He has been with Dow Jones & Company for 27 years, including the past 19 years at Barron’s. Mr. Bary now writes feature stories on a wide range of topics. He was named a senior editor at Barron’s in 1995 and an associate editor in 2006.

    In 1983, Mr. Bary joined Dow Jones as a reporter for the Capital Markets Report (CMR) one of the Dow Jones newswires. He worked as a reporter and editor at CMR before joining Barron’s.

    A Brooklyn native, Mr. Bary earned a bachelor’s degree in history from Princeton University in 1983. He lives in New Jersey with his wife and two daughters.

    Sentiment: Strong Sell

  • Elizabeth Holmes finally admitted their Edison Machine was not working as expected and withdrew 2 years of testing.

    That was a Billion $ Plus company.

    The lesson here is that technology must be proven and that the list of people "on board" simply is not scientifically derived testing evidence. Having people on CNBC talking about how great and game changing and tech disrupting the technology is does not prove it, either. I'm willing to bet Rubio did not run any controlled testing in conjunction with Sarepta. The proof is in the ambulation data. Make That End All Test.

    On a side note.... this is entirely a curious question -- did Sarepta utilize Theranos for any of their safety testing data? e.g. checking renal and hepatic function

    I hope not.

    Sentiment: Strong Sell

  • Reply to

    For u newbies

    by thigrlsrk May 28, 2016 7:30 AM
    msmorrisine msmorrisine Jun 3, 2016 2:56 PM Flag


    Their ambulation data definitively showed the FDA how wrong they were and the FDA approved eteplirsen?

    you're lying about me lying, but not acknowledging reality is par for the course around here.

    If the kids all won gold medals in Sochi and set new world records, we wouldn't be talking. We'd be celebrating Sarepta's success.

    If the ambulation data showed what is being figuratively shouted about ("kids are running") we would not be here either.

    Sarepta blew it starting Oct/Nov 2013 all through to today by not having a better testing regime. And the sad fact is that they were told by the FDA to change, but they did not. The FDA is being hung out to dry here, but it should be Sarepta, who could have simply added a new, better and much more compelling test but chose not to do that. *Why not?*

    Sentiment: Strong Sell

  • Reply to

    For u newbies

    by thigrlsrk May 28, 2016 7:30 AM
    msmorrisine msmorrisine Jun 2, 2016 4:04 PM Flag

    And they had documented, properly controlled testing to rely upon?

    Or do we just supply their ph # to everyone who wants to know about the effects of eteplirsen on exon 51 DMD kids and let them explain how they feel regarding their limited exposure to exon 51 kids being treated with eteplirsen as compared to untreated kids?

    One of the reasons to have a broad, controlled study is to rule out inter-patient variations which may occur and other things which may affect test results.

    If the capabilities were so clear cut.... WHY DIDN'T THE TEST DATA SHOW IT?

    that's a HUGE issue.

    Sentiment: Strong Sell

  • Reply to

    For u newbies

    by thigrlsrk May 28, 2016 7:30 AM
    msmorrisine msmorrisine Jun 2, 2016 3:02 PM Flag

    ...Since Oct/Nov of 2013 people...

    Sentiment: Strong Sell

  • Reply to

    For u newbies

    by thigrlsrk May 28, 2016 7:30 AM
    msmorrisine msmorrisine Jun 2, 2016 2:44 PM Flag

    My reply

    We can talk of Dystrophin production and debate levels. 0.9%? 50%?

    The end result is what was contained in the original reply above and not dealt with:
    "kids are running!" but the test data does not indicate they are doing anything outside what an untreated kid can do.

    Thus the problem:
    27 months ago (more...) Since Oct/Nov people, parents, Sarepta have been adamant that the kids are so much better off taking eteplirsen, but the FDA told them they did not see it in the data and their testing was inadequate.

    Here we are 27+ months later and the same statements are coming from everyone really. "It works." "The kids aren't performing any better than what untreated kids would."

    Sarepta had the chance 27+ months ago to say "We're going to PROVE the FDA wrong and embarrass the hell out of them by showing what these treated kids CAN do."


    That is a HUGE issue that must be addressed.

    The way NOT to address it is through a "kind of" petitioning (it's not a petition literally, but figuratively) by having Congress, letters, emails, and other pleadings to try to take the place of a proper testing regime.

    Seriously, a child could come up with a test that shows the mobility difference of kids that can barely walk as compared to "kids are running."

    The fact that such has NOT been done raises serious questions. The fact that pleadings are trying to replace that is problematic for the overall drug approval process. When pleadings replace science for drug tests, the FDA may as well roll over and approve Extenze penis pills.

    I want to believe the parents of the kids, at this point I'm more or less pleading for them to stop pleading to the FDA and for them to start pleading to Sarepta to come up with a new test that will lay doubt to rest regarding their kids' capabilities.

    The lack of performance data is HUGE, especially after being warned 27 months ago of THE SAME THING!

    Sentiment: Strong Sell

  • Reply to

    For u newbies

    by thigrlsrk May 28, 2016 7:30 AM
    msmorrisine msmorrisine May 28, 2016 12:44 PM Flag

    for u newbies

    thigrlsrk was here in Oct 2013 telling everyone that eteplirsen would be approved because the kids were running.

    This was at double the current share price.

    Sarepta chose to use #$%$ testing to try to "prove" what they were saying, then brought in multitudes of people to effectively petition -- although it was not a petition nor a written one it was in effect a petition through a show of bodies testifying for approval -- the FDA for approval.

    Sarepta could have provided a much better testing protocol over the intervening 27 months from Oct/Nov 2013 to now, but they did not. Whether their e. coli testing/drug was ok or not is totally irrelevant. This is far from e. coli and far from the testing regime for e. coli treatment.

    And this thread is essentially showing the mindset of the people pounding the table for approval of eteplirsen. Proven science is not on their radar.

    Sentiment: Strong Sell

  • Reply to

    The Obvious In Today's Delay

    by msmorrisine May 25, 2016 7:50 PM
    msmorrisine msmorrisine May 25, 2016 9:06 PM Flag

    Approval merely needs "YEARS" and "time"???

    Extenze pills have had "time" and "YEARS" on the market. You would approve Extenze pills then? Hm? No?

    Approval comes from PROOF and That only comes from _GOOD_ TESTS that generate data that DEMONSTRATeS RESULTS.

    If the parents are right, the failure here is with Sarepta and their faulty tests.

    Unfortunately, written pleading words are no more proof than having 1 billion pills sold.

    Sentiment: Strong Sell

  • Reply to

    The Obvious In Today's Delay

    by msmorrisine May 25, 2016 7:50 PM
    msmorrisine msmorrisine May 25, 2016 8:23 PM Flag

    Autocorrect run amok

    Pulses - pills
    Pulls - pills
    And more son is more so

    Sentiment: Strong Sell

  • Reply to

    The Obvious In Today's Delay

    by msmorrisine May 25, 2016 7:50 PM
    msmorrisine msmorrisine May 25, 2016 8:21 PM Flag

    I never said there were proven health risks.

    The risk is to the process. There must be proper tests with proper data SHoWInG efficacy. There is none here.

    I see on Yahoo ads for Extenze pulses with over 1 billion pulls sold. Surely with no risks and the company can find users who says it works, the Extenze pulls can also be approved?

    No. The data in a proper test would not show it.

    The same is true so far with eteplirsen. But I do heed the parents advice that there are signs of efficacy. So, my recommendation is for proper tests to PROVE what the parents say.

    Unfoetunately, only a moron would suggest a simple statement refutes anything and even more son from anyone with an advanced degree. No. proof must lie within data.

    If the kids are doing wonders MAKE A _GOOD_ TEST AND PROVE IT.

    Sentiment: Strong Sell

  • msmorrisine msmorrisine May 25, 2016 7:55 PM Flag

    It is obvious day.

    You have obviously been trying to talk this stock Dow to obviously no effect. I hope for everyone's sake you have millions at stake. I hope we haven't been going through your incessant bs over a few hundred shares.

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