Recent

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

Genomic Health Inc. Message Board

mdwhittier 221 posts  |  Last Activity: 10 hours ago Member since: Sep 17, 2012
SortNewest  |  Oldest  |  Highest Rated Expand all messages
  • Reply to

    Drisa from twitter

    by thigrlsrk May 1, 2015 7:30 AM
    mdwhittier mdwhittier May 1, 2015 10:34 AM Flag

    How could there possibly be over 1M pages? That sounds preposterous. And, (if true) how could the FDA possibly wade through all that in a timely manner?

    Sentiment: Strong Buy

  • Reply to

    Drisa from twitter

    by thigrlsrk May 1, 2015 7:30 AM
    mdwhittier mdwhittier May 1, 2015 3:27 PM Flag

    Guess the strategy is to overwhelm them with data, and then voila, show them the perfectly mined and arranged data of a small subset of boys that shows clinical utility. Oh, but never mind that we don't have dystrophin data, or that our large Ph3 failed miserably, or that our drug is toxic at a clinically helpful dose range. It's the "we can exon skip with the best of them" shuck and jive. Just don't look too deep under the hood.

    Sentiment: Strong Buy

  • Srpt hit the close today at $12.72 up 52 cents on the day. At 4:02 pm there was a sell trade of 3,300 shares at $12.20. Then, an 8,400 buy at $12.43 to cut the day's close just under half. Then, some buys going up to $13. Now, a little over 20k shares traded after hours, mostly buys. Trades at 4:26pm ET at $13.35 followed by 1,500 shares at 4:31pm at $13.12. Kinda unusual to have over 20k shares trade after hours for SRPT.

    Sentiment: Strong Buy

  • Reply to

    Crazy After-hours Trading

    by mdwhittier May 1, 2015 4:38 PM
    mdwhittier mdwhittier May 1, 2015 4:53 PM Flag

    Yeah, just saw that on a Twitter feed. 5.3% passive stake and an increase of 600k shares since last filing. That's a nice vote of confidence, since he's a super savvy hedge fund manager. Should be interesting on Monday. With this news shorts will start to get really.

    Sentiment: Strong Buy

  • Reply to

    Crazy After-hours Trading

    by mdwhittier May 1, 2015 4:38 PM
    mdwhittier mdwhittier May 1, 2015 5:18 PM Flag

    Maybe not so insane. A lotta traders recognize that Seven Cohen of Point 72 is a very smart investor, so he must think risk/reward favors being long SRPT right now. And yes, it couldn't come at a better time.

    Sentiment: Strong Buy

  • Reply to

    Crazy After-hours Trading

    by mdwhittier May 1, 2015 4:38 PM
    mdwhittier mdwhittier May 1, 2015 5:48 PM Flag

    ....nervous. It's about time for SRPT to get some wind under its wings.

    Sentiment: Strong Buy

  • Reply to

    Crazy After-hours Trading

    by mdwhittier May 1, 2015 4:38 PM
    mdwhittier mdwhittier May 1, 2015 6:38 PM Flag

    "His position is inconsequential". Sorry that your willie is shooting blanks, but it goes along with your statement, which is kinda limp. What his position does show is confidence, and $25mil bucks isn't pocket change, regardless of your view. Good luck with your short, willie.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier May 3, 2015 2:26 PM Flag

    Interesting Comment under the NYT article from poster: Honolulu - "There's a swinging door between the FDA and the pharmaceutical industry. Top FDA officials are appointed from industry (Michael Taylor is FDA deputy director), and they return to well-paying positions in the industry they used to "regulate" when they leave the FDA. The scientists are usually competent but ignored when their advice will hurt industry's profits".

    Sentiment: Strong Buy

  • mdwhittier mdwhittier May 3, 2015 2:39 PM Flag

    About Michael Taylor, from Wikipedia: "Taylor is featured in the documentaries The Future of Food and The World According to Monsanto as a pertinent example of revolving door since he is a lawyer who has spent the last few decades moving between Monsanto and the FDA and USDA."

    bf109gee: I think wrt the FDA feeling "the heat" they seem to have a Teflon heat shield in place, and are able to engage in "FDA Fed speak" so that they appear to be flexible, yet behind the scenes are involved in complex political maneuvering to pander to big pharma.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier May 4, 2015 6:21 PM Flag

    And today's 4.28% gain was on the heels of news about probable future dilution. So, by your sights, we should have closed red. You might want to recheck your facts.

    Sentiment: Strong Buy

  • Look at it this way. Srpt has a 35 mil float; really small. BMRN has a 158 mil float. Granted, BMRN has revenue, but it wasn't always that way. The clinical trials for exon skipping that SRPT is engaged in are very expensive, as will be the rest of R&D for the PPMO platform. Raising revenue by share offerings is just SOP for biotech; gotta feed the beast. In any case, whether or not SRPT ends up being sold, the cash runway won't hurt if clinical development for all exons in question turns out positive. But meaningful revenue won't be for a couple more years, right? Look at GEVA's chart, which suffered a 1:5 reverse split Oct.31, 2011. Whether we like it or not, Srpt will need the cash, and dilution can't be helped. We could end up like GEVA in a year or two and who knows, BMRN might just get swallowed up by a larger fish, which will make Srpt even more enticing. Especially if RNA's Drisa gets a thumbs down at AdCom. Srpt is actually more attractive with a big cash hoard. I'm sure they won't raise until the share price is above $20.

    Sentiment: Strong Buy

  • Reply to

    Simp

    by thigrlsrk May 6, 2015 9:24 PM
    mdwhittier mdwhittier May 6, 2015 10:29 PM Flag

    C'mon, thigrlsrock, we all know you really don't know the final "D" numbers, since that would be insider information, which is highly unlikely that you would know. So, let's just figure that you are extrapolating from past "D" measurements, which were probably valid, and which were corroborated by the independent labs that did the 4th biopsy. But it makes for good speculation, all the same. Why would the new readouts be substantially different from the other ones? Better for some of the cohort but stable in others, is my guess. Too bad there isn't a way to check "D" as related to pulmonary function. What we do have is solid pulmonary data, in terms of respiratory muscle function tests, so one can infer that increased D is the reason. Those muscle tissues haven't experienced fibrosis, like the leg muscles, and therefore are able to benefit from Etep. therapy.

    Sentiment: Strong Buy

  • Reply to

    so there you have it

    by simp08801 May 7, 2015 7:34 AM
    mdwhittier mdwhittier May 7, 2015 9:50 AM Flag

    Just down b/c reported losses for the quarter were much higher than "street" expectations. No big deal, since the cost of launching the new trials was not baked into the street's guidance models. No surprise there.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier May 15, 2015 6:32 PM Flag

    Indeed it is possible that all your "what if" questions are eventually shown to be completely misguided and malicious. I'd say when the NDA is filed your position will then shift to some other negative nonsense that you will repeat in many different forms until you are proven wrong, again and again. Beloved? I'd say you are delusional.

    Sentiment: Strong Buy

  • Let's face it folks; SRPT has now met all requirements of FDA, that were roadblocks in previous NDA filing timelines, due to add-on requirements by FDA. Those roadblocks now have been removed, and the confirmatory trials presumably have shown no toxicity issues (which had been a big ? for FDA).

    I think there's every good reason to believe that FDA will treat the filing as a modified rolling NDA, with efficacy data to be added at 24 weeks, which will be available to the AdCom. The totality of positive data, both safety and efficacy, will certainly be head and shoulders above RNA's Drisa.

    As previously mentioned here, there's a very good chance of AA coming on the heals of the AdCom meeting. And, it would surprise no one that upon AA, FDA would then crow about partnering with SRPT to bring this life saving drug to kids with DMD. The shorts have ridden the "low N" train for serious gains & hats off to them for being right. The train has now been retrofitted, and is capable of much greater acceleration than ever before. Only so much time for shorts to jump off.

    Sentiment: Strong Buy

  • Reply to

    Stars Lined Up for NDA Filing

    by mdwhittier May 18, 2015 3:11 PM
    mdwhittier mdwhittier May 18, 2015 4:10 PM Flag

    I'm thinking more along the lines of "efficacy" as reported by anecdotal reports from parents, which the FDA has been very open to hearing about. Sure, it's possibly a placebo effect, but it's also quite possible that it's a leading indicator of efficacy. It's additional "data" - from the trenches, if you will; what parents are observing on a day-to-day basis.

    Sentiment: Strong Buy

  • Reply to

    Stars Lined Up for NDA Filing

    by mdwhittier May 18, 2015 3:11 PM
    mdwhittier mdwhittier May 18, 2015 4:19 PM Flag

    Thank you! There may be some thread-bare DNA, buried amongst all those strands. I'm no poet, but I strive to write legibly and clearly. Been on board since the AVII days, many years ago. It's been a tough ride but I've believed in the science. Right now, I'd like to see a win for the boys with DMD, and their families. The rest will take care of itself. I'm in for the long haul.

    Sentiment: Strong Buy

  • Reply to

    Stars Lined Up for NDA Filing

    by mdwhittier May 18, 2015 3:11 PM
    mdwhittier mdwhittier May 18, 2015 4:51 PM Flag

    There are different types of efficacy "data"; don't discount anecdotal reports from parents. Those matter too, and will be available by AdCom. Those types of data points are already coming in.

    Sentiment: Strong Buy

  • Reply to

    Stars Lined Up for NDA Filing

    by mdwhittier May 18, 2015 3:11 PM
    mdwhittier mdwhittier May 18, 2015 5:51 PM Flag

    O.T. - But, the dystrophin data, as biomarker, would be big points towards AA if those were consistently positive. Also, I find it very interesting that FDA didn't require 4th biopsy "D" data in their NDA requirements. Perhaps this information wasn't requested because the summit meeting to discuss reliability of I.F. and Western Blot hadn't happened yet. It now seems that FDA is comfortable with these tests, and should be completely comfortable with the results from the 3 independent labs for the 4th biopsy and any re-reads that occurred. Also, it seems the "market" is saying "risk on", since the not-too-distant-past mid $12's held. Nice bounce, I'd say.

    Sentiment: Strong Buy

  • Reply to

    Stars Lined Up for NDA Filing

    by mdwhittier May 18, 2015 3:11 PM
    mdwhittier mdwhittier May 18, 2015 7:10 PM Flag

    Great response, jrrt1, and thanks for elucidating those points!

    Sentiment: Strong Buy

GHDX
27.08+0.74(+2.81%)Jul 31 4:00 PMEDT