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  • Karyopharm Therapeutics: Will It Be An EPIX Fail? [View article]

    Unfortunately, a lot of people already did buy at $42, $43, $44, $45, $46, and $46. Just look at the chart. Same pattern as last March. They high a high price, and dilute with 4M share registration. From there it drops just like it is here. This past June same pattern.

    This stock is just an ATM machine for the CEO and CSO, and it is investors who are restocking the ATM machine. Everyone is focusing on the medical promise and purported claims of some Phase I trial data here.
    Jul 23, 2014. 10:21 PM | 1 Like Like |Link to Comment
  • Karyopharm Therapeutics: Will It Be An EPIX Fail? [View article]
    In the KPTI trial, we saw Selinexor alone, at best, in high dose had a very low Overall Response Rate of 6%, or 1 whole person. No complete response.

    Now add Dexamethosone, which in itself is an effective treatment of Multiple Myeloma. As to how much? You saw 18%, I saw 43%. We could probably spend all day finding different #'s in different studies. This is not the point, its subjective, the fact we agree on is that it does have a significant response rate......and its higher than Selinexor.

    So you have a trial, Selinexor itself shows small response rates, now you add Dexamethosone and suddenly you have these spectacular results. It cant be proven here that Selinexor contributed anything to those results. The results of Selinexor by itself are right there, and they are not great. I can see people have really drank into the Kool Aid here.

    Here is maybe a more simpler way to explain it. You have a glass of Kool Aid, you drink some but it is not getting you drunk. You now add some Vodka, drink some and now you are getting drunk. Would you then try to tell me that the Kool Aid, not the Vodka gave you your buzz?
    Jul 23, 2014. 10:13 PM | Likes Like |Link to Comment
  • Karyopharm Therapeutics: Will It Be An EPIX Fail? [View article]
    No debt? Really? Selinexor is keeping people alive? Little thing called proof.
    Jul 23, 2014. 09:57 PM | Likes Like |Link to Comment
  • Karyopharm Therapeutics: Will It Be An EPIX Fail? [View article]
    Thank you Leonard for your comments, and your medical opinion. You may be right, you may be wrong, but the issue at hand here is that the trial data presented doesn't support your claim.

    I do my analysis from the perspective of an investor rather than a medical professional. I look at things like if a company times huge insider selling and dilutions in sync with PR. That's great for the company and its CEO because they rake in a bunch of cash, but they do so at the expense of investors, and that is my target audience here, not the medical community. Those who bought in at $42.50 and up already lost $8-10 a share. I don't invest in biotechs based on emotions or the ailment that a company's drug hopes to cure. Some invest this way, but most don't because the former doesn't last very long.

    Even if we assume for a minute you are right,the points I tried to made with EPIX was that it also had several promising drugs, but that doesn't mean that you can succeed as a biotech company. You can fail financially, you can run into roadblocks with the FDA, there are many risk in biotech.

    Sorry Leonard, but there are just too many red flags on this one for me.
    Jul 22, 2014. 07:47 PM | 1 Like Like |Link to Comment
  • Daily Round Up: 7/2/14 [View article]
    How on earth is the insider selling at KPTI Insignificant? First off you fail to mention that the CEO and CSO EACH dumped $8.5M, not just the CEO. Secondly that is 25% of their ownership. That information coupled with the fact that they just pumped a huge secondary, and is actually the 2nd time they have sold shares in only 2 weeks.....well, I guess its only insignificant if your a bag holder.
    Jul 3, 2014. 10:20 AM | Likes Like |Link to Comment
  • What The FDA Document Says About Afrezza: Implications For FDA Approval [View article]
    Just an off the wall observation, but I find it hilarious anytime the FDA talks about limiting a label of a drug for people who smoke those cancer sticks. Tobacco use and the cancers it in itself causes are horrible things. Great strides have been made in the past 10 years to educate people and ban smoking in public places. Why doesnt the FDA do more to curb tobacco use in the first place rather than curbing drugs for people who use tobacco?
    Mar 30, 2014. 03:14 AM | 4 Likes Like |Link to Comment
  • What The FDA Document Says About Afrezza: Implications For FDA Approval [View article]
    tuduong11 is absolutely correct. No where in 249 pages does it say the FDA is onderwhelmed or overwhelmed. Also, no where does it indicate the FDA has pulled back support.

    The questions are quite objective and simply ask if the committee feels Afrezza is safe and if it should be approved. Every ADCOM asks questions very similar. If anything, I think the questions are quite positive.

    If anyone was not expecting questions from the FDA for the ADCOM, they clearly dont have experience with ADCOM meetings.
    Mar 30, 2014. 03:12 AM | 2 Likes Like |Link to Comment
  • MannKind And Afrezza's NDA Evaluation: What Is The Real Justification For The Advisory Committee? [View article]

    Thank you for writing this. Probably one of the most informative article on diabetes in general I have read to date.

    Mar 28, 2014. 05:35 AM | 1 Like Like |Link to Comment
  • MLV Sees A Good Chance Of FDA Approval For MannKind's Afrezza And 60% Upside [View article]
    Great article. I also feel that the $9 target is a bit low. That puts the company at about $4-$5 billion market cap. There are several factors here that I think will result in a much higher price once this is approved:

    1) The short squeeze - there is over 16% of the float short. Considering Al holds something like 40% of the shares and isnt day trading them, that 16% will behave more like 30%.

    2) The insulin inventory on hand - Once approved, this will put an estimated $10 billion in inventory on the books. My understanding is that they are currently not including this from an accounting perspective. We know from monitoring the jobs available at Mannkind, as well as PR from the company that there have been extensive efforts in Danbury to ramp up the manufacturing and to "hit the ground running" once the FDA approves. If you put the $10 billion on the books, thats a $20+ pps which doesnt even take into consideration the intellectual property and Afrezza rights.

    3) The growing diabetic market - There are lots of numbers being thrown around out there between $30-$40 billion per year. Just capturing a small portion of that market is huge. Biotech companies are often valued based on potential rather than actual sales.
    Mar 18, 2014. 08:07 PM | 4 Likes Like |Link to Comment
  • What Can The Deerfield Conversion Tell Us About MannKind Going Into ADCOM? [View article]
    Black Gold,

    I have to respectfully disagree that an Adcom is a negative. A CRL is a negative. Given the history of MNKD, any decision making behind closed doors is a negative. The Adcom is a open to public and webcasted forum, and there is nothing negative about that unless you know for a fact that there is a "Black Swan" in the unreleased trial data.

    Thats really what this whole thing comes down to: gambling on if there is a "Black Swan" hidden in the unreleased trial data.
    Mar 13, 2014. 07:21 PM | 2 Likes Like |Link to Comment
  • What Can The Deerfield Conversion Tell Us About MannKind Going Into ADCOM? [View article]

    You are correct on the independent experts. Deerfield never directly saw the full data. They have thought this out, and are not the fools some seem to want to make them out to be.
    Mar 13, 2014. 07:21 PM | Likes Like |Link to Comment
  • MannKind: Follow The Smart Money [View article]
    Good point on the JDRF Study Kevin. I seriously hope MNKD can some way introduce these results at the Adcom, even if they weren't part of the clinical results submitted to the FDA in the NDA. Perhaps that will require someone from the JDRF to be a speaker in order to introduce the information, which I think is highly relevant.
    Mar 10, 2014. 08:02 PM | 4 Likes Like |Link to Comment
  • MannKind: Follow The Smart Money [View article]
    Good point on the respectfulness George. You could have titled this article "MannKind: Follow Those Being Professional". The tactics of short sellers in this case is almost one for the textbooks.
    Mar 10, 2014. 08:02 PM | 5 Likes Like |Link to Comment
  • MannKind: Follow The Smart Money [View article]
    Great article, and spot on. Thanks George!

    I am very surprised by the lack of a run up though. Maybe it is coming next week. To think this hit $8.70's on anticipation of phase 3 results (which were positive), I dont see what has changed since then. Even the likes of AF agree that the FDA will likely approve.

    Regardless, what is most important is the end game. Going into Adcom oversold will just make this a bigger launch pad once approved.
    Mar 10, 2014. 08:01 PM | 2 Likes Like |Link to Comment
  • How Will Subconscious Issues Influence FDA AdCom Voting On Afrezza? [View article]
    " I wouldn't shock me to hear that the Adcom would like for there to be a long term outcomes study that absolutely makes sure that there isn't any lung cancer complications etc."

    Alfrezza has already been studied longer than most drugs out there by way of 2 CRL's. None of the people in original trials nearly a decade ago have developed any lung cancer.
    Mar 6, 2014. 01:35 PM | 6 Likes Like |Link to Comment