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Idenix Pharmaceuticals, Inc. Message Board

value_investor_12 33 posts  |  Last Activity: Dec 5, 2014 1:50 PM Member since: Mar 26, 2014
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  • value_investor_12 value_investor_12 Dec 5, 2014 1:50 PM Flag

    If you look at the most recent changes their target enrollment is 67. They expanded their sites from US only to US and Canada. Nationwide is also recruiting in RNA's trial but the PI is Kevin Flanigan, not Jerry Mendell, their senior DMD expert.

    Things are looking good. The stock price will follow. Like it followed VRTX, GILD, IDIX, all stocks that did well but had temporary setbacks when the science and market looked so good.

    That is why I am in biotech. It is relatively easier to beat the market if you know your science and you don't need to be a financial expert if you have that strong background in science. SRPT as of now is a trader's stock with ups and downs that reflect that.

    SRPT's day will come and when it comes, it will come big. The only risk I see as of today is the unpredictable politics of the FDA.

    Sentiment: Strong Buy

  • The QnA session was very telling. You can see who was the one emotionally dedicated to the cause (it was clear in her voice; makes sense because it is a matter of life and death for their child) vs the politician who knew what to say (likely because more and more people are sick and tired of the fact that they are not backing eteplirsen and are moving away from her organization) vs the investor who cared about their investments more than the boys (the question was more fit for an investor's meeting). It was very interesting. All fighting for the same cause, all with slightly different interests. I do think the politician is realizing that she cannot survive without backing eteplirsen, thus the question that she asked, which she knows the answer to already. The investor... not much to say about her. Hopefully the truth comes out. And the parent, I wish her the best and am gland that you boy is finally after all these years, getting the drug that he deserves.

    What a story. Hopefully one day, this becomes a movie and we will know the truth.

    Sentiment: Strong Buy

  • 1. they are not concerned about dystrophin. They will proceed with the 6MWT as their end point. Not sure if this is a viable plan to proceed thereafter with the more rarer exons.

    2. The little response in the subgroup of patients age greater than 7. They are hopeful that these patients just need more time. They used their enzyme deficient patient population that advanced patients just need more time. Not sure if they know that once your muscle develops fibrosis, it is impossible to bring back. The advanced patients likely did not respond as well because the damage was already done. Based on the data that we have, dystrophin restoration works best and has the biggest impact when given at a young age before the damage is done.

    3. Impression is that BMRN does not have much experience in the duchenne world. They think restoring dystrophin is somehow similar to restoring deficient enzymes. The rare diseases they treat is very different from duchenne but they are treating it as if they are similar.

    BMRN may get approval but in the presence of eteplirsen, very few would likely prescribe eteplirsen. And I do think BMRN does not know much about duchenne, other than whatever RNA has told them.

    Sentiment: Strong Buy

  • Reply to

    JJ Bienaime-the new Hans

    by whatmeworriee Dec 3, 2014 8:36 PM
    value_investor_12 value_investor_12 Dec 3, 2014 8:38 PM Flag

    the market is never wrong in the long term. It's been less than a week. I would say it is too early to figure out what the market is saying.

    Sentiment: Strong Buy

  • value_investor_12 by value_investor_12 Dec 1, 2014 1:13 PM Flag

    CG stated that only 16 patients out of 90 have been recruited in the RNA re-dosing study. Does anyone know where he got this information? I do think that the fact that RNA is not able to fully enroll a study consisted of patients who have been exposed to drisapersen is very telling. SRPT has 12 patients in their study, no drop outs, willing to do a 4th biopsy, with much travel. Also the SRPT safety study enrolled very quickly and was closed in almost 1 week.

    I do think CG needs to eat some humble pie. He has a great molecule, but his arrogance I think makes a lot of people uncomfortable. (I could still feel that in the DB fireside chat.) I think RNA has an inferior compound (they know it) but their humble attitude got them to where they are. I may be wrong. I am sure CG's aggressiveness and arrogance was a major factor in bringing AVI from the dead but he has to change his strategy now. He needs to be more of a politician. Just my opinion.

    Sentiment: Strong Buy

  • value_investor_12 by value_investor_12 Nov 24, 2014 10:27 PM Flag

    Hans is a very good salesman.

    I can't stop thinking that this was his strategy afte the phase 3 failed.

    Sell drisapirsen before anything gets to market. Because even if the FDA approves this drug, the market will not approve this drug in the presence of a better alternative.

    Sentiment: Strong Buy

  • value_investor_12 by value_investor_12 Nov 24, 2014 1:04 PM Flag

    BMRN seems to be downplaying the importance of dystrophin. Either they know something, or don't know much. We know drisapersen does not have a robust dystrophin data set so the fact that they are (and have been) down playing the dystrophin results makes sense but I was under the impression that dystrophin measurement standardization is a key factor in the approval of exon skipping drugs in the field of DMD.

    I do think in the short term, people with power, influence will have their way. But in the long term, as always, the market will side on facts and science. It will take some time though.

    Sentiment: Strong Buy

  • value_investor_12 by value_investor_12 Nov 24, 2014 12:30 PM Flag

    BMRN CEO, when asked a question regarding "how are you going to convince the FDA regarding the lack of efficacy in the older patient population." answered that "late therapy may take a longer time to see the benefits" in these patients with more advanced disease. The problem with that quote is that if you have viable muscle you should see benefit at 1 year because the advanced patients are the ones that decline fast and the benefits should be amplified in this patient population unless everyone stops walking which wasn't the case in the phase 3 drisapirsen study. The other problem is that if you don't see benefit, you most likely will never see benefit in terms of 6MWT because exon-skipping does not reverse fibrosis.

    The following comment that they have seen this phenomenon before in their enzyme replacement studies, where the earlier the better but delayed treatment just takes longer to see the benefits concerns me that they are thinking DMD like an enzyme deficient disease, which it is not. DMD leads to fibrosis which cannot be reversed. Early treatment is crucial and that is why time matters so much. You don't get to walk again once you become non-ambulant with exon skipping. The clinicians and patients know this. The investors do not.

    Sentiment: Strong Buy

  • value_investor_12 by value_investor_12 Nov 18, 2014 11:30 PM Flag

    "This study is ongoing, but not recruiting participants." on clinical

    Either something went really wrong but more likely the people in line for to get screened will likely fill the numbers that is needed for this study. The demand for eteplirsen is high. Reminds me of the HCV studies which would close fast.

    "It's a game changer."

    People involved in the research knew about this with sofosubuvir (PSI-7977) way before it hit the market and started to get attention. It is the same with eteplirsen. It is a game changer and shallow gamblers are paying attention to the ups and downs of stock prices, thinking that there is something "deep" with these price actions when in fact there isn't. The science hasn't change when this stock was at 50 and it hasn't change even if it down at 10. The patients, parents and providers want THIS drug. The line for eteplirsen is long. The fact that the safety study closed in 1 week is the proof.

    Hang on people. You are in for a ride.

    Sentiment: Strong Buy

  • value_investor_12 value_investor_12 Nov 11, 2014 9:45 PM Flag

    Thank you Christine for your comments. As an investor and a practicing physician, I have nothing but respect for you. Just remember that advocates have played an important role in shaping policy of diseases that the government does not have a grip on. HIV is a classic example where advocacy played a major role in developing new drugs. We can now say that HIV is a chronic disease that is easily manageable due to the investments that were made my companies because the market situation was made much more favorable because the policies of our government changed.

    I believe you are doing the same. You are fighting for your boys but also paving the way for children with rare diseases where developing a drug can be very challenging for many reasons, including outdated government policies.

    I hope the FDA turn around and do what makes sense. I am SRPT long and will be until Jett and many boys are allowed access to eteplirsen. This is what investing is all about.

    Sentiment: Strong Buy

  • value_investor_12 by value_investor_12 Oct 30, 2014 4:05 PM Flag

    You invest in the people, the cause, the science. The finances need to be strong. And you pay less attention to the ups and downs of the stock price. The dirty politics are less important in the end.

    Those who stayed long $SRPT, hang tight. Our time will come.

    Sentiment: Strong Buy

  • value_investor_12 by value_investor_12 Oct 27, 2014 8:44 PM Flag

    A letter from Pat Furlong. She knows politics. She knows the FDA. Her letter is good. I never thought I would say this but thank you PPMD.

    CG, thank you for all the work that you have done so far, but you do not know how to talk with the FDA. So please stay out of those meetings.

    Sentiment: Strong Buy

  • Reply to

    Reflect on this a bit

    by winterlion7722 Oct 27, 2014 10:34 AM
    value_investor_12 value_investor_12 Oct 27, 2014 10:47 AM Flag

    Yes, unfortunately the FDA has shown that it is not a friend of this company. Their decisions today clearly demonstrate that politics is also an equation that needs to be considered in the approval of this drug. PPMD is a powerful organization and will likely say nothing regarding this decision. Smaller charities will shout out. I hope they win. What a dirty game this is. But in the end, they cannot ignore the science. I just hope that the behind the scenes politics of this dirty game is not as dirty as I think it is.

    Sentiment: Strong Buy

  • value_investor_12 by value_investor_12 Oct 24, 2014 3:13 PM Flag

    Just for fun

    There was a rare disease roof top partnering reception on June 24 2014. (google "rare disease roof top")

    Ms. BL from Shire, a business development consultant, was there. Her specialties based on linkedin is as follows:

    "Valuations, mergers and acquisition, divestitures, managing virtual due diligence processes, alliance management."

    CG, BC, KB was also there. All people who are key in partnering with other companies.

    My guess. SPRT is interested in working with other companies if the condition is right. SHPG is interested in SRPT. The question is are they interested in buying them or partnering with them. Is SRPT interested in being bought.

    These are all guesses and obviously SRPT has a very high bar for companies who are interested in working with them.

    Some gossip, just for fun. Nothing to be taken seriously.

    Sentiment: Strong Buy

  • Reply to

    I have a feeling

    by brad_210000 Oct 15, 2014 3:38 PM
    value_investor_12 value_investor_12 Oct 15, 2014 4:03 PM Flag

    I have the same feeling too, but he will come back tomorrow when SRPT falls again:)

    Sentiment: Strong Buy

  • value_investor_12 value_investor_12 Oct 14, 2014 5:58 AM Flag

    This was his piece on Idenix prior to being acquired by Merck:

    Foolish wrap-up
    Despite the rising short interest in Idenix, shares have rallied this year, climbing higher by nearly 10% year to date. With that said, I think this rise in share price has been driven mostly by the excitement over Sovaldi's record breaking sales and a general sectorwide leg up over the past few weeks. When we dig deeper into Idenix's prospects moving forward, I don't see much to be enthusiastic about. The hepatitis C market is certain to change after the introduction of what amount to a handful of functional cures. So, if it's able to get a drug approved, Idenix's hopes for commercial success may hinge on their ability to compete price-wise, which translates to lower margins. Overall, you may want to exercise caution with this developmental biotech.

    He is not a man of science.

    Sentiment: Strong Buy

  • It tells me that the market does not understand what is goin on and is just reactig to press releases rather than knowing something of importance.

    Sentiment: Strong Buy

  • value_investor_12 value_investor_12 Oct 11, 2014 4:27 PM Flag

    Yes i meant gutsy to approve drisa.

    Sentiment: Strong Buy

  • RNA has no plaecbo arm. Which makes it even more difficult to assess efficacy. Remember this study was a safety study.

    The big difference would be the adverse events. Injection site reactins, proteinuria, thrombocytopenia. It is not a safe drug that you can administer for many many years.

    FDA would have to be pretty gutsy to approve this drug. Especially since there is an slternative. In the end it is about providing the safest and most effective drug to patients.

    Sentiment: Strong Buy

  • value_investor_12 value_investor_12 Oct 11, 2014 6:58 AM Flag

    Also note that after 24 weeks when etep starts kicking in, all are still ambulatory. And of course no significant adverse events.

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