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  • Shares Of Ventrus Biosciences Are Poised To Return To $12 [View article]
    You have a fundamental error in your first sentence. The company did not report yesterday "that the Phase III clinical trials for its diltiazem cream (VEN 307) were successful". In actual fact, the company reported successful results from a couple of dermal safety studies and a pharmacokinetic study. These studies were required by the FDA for the eventual NDA. The phase III efficacy results were, if anything, delayed. Previously the company had given guidance for late Q3 or Q4 for those results. Now they have pushed that back to Q1 2014 and seem to have added sites in Europe to complete the enrollment.

    The first sentence of the 2nd paragraph is also erroneous. There is existing competition. Rectiv (a nitroglycerin (GTN) ointment marketed by Aptalis) was approved by the FDA in 2011 and is available for the treatment of chronic anal fissure. In addition, doctors have the option to request pharmacists to compound diltiazem.

    Your contention that surgery is currently the best option is also incorrect. Treatment of AF follows an algorithmic approach. 1st line is simple, lifestyle measures (diet, hygiene, stool softeners, etc). 2nd line is topical pharmaceuticals (GTN, diltazem, potentially Botox). Surgery is a last resort.
    Sep 12 01:44 PM | 9 Likes Like |Link to Comment
  • Monthly Trading Of MDY, MVV And UMDD [View instapost]
    Could be.

    I have never spoken with anyone there but it appears to be a well-run company. They have a solid onc. focus with decent products in reasonably attractive markets. Also seem to have good clinical development programs supporting their marketed products. The upcoming PDUFA date for Stivarga may move the price but probably not by that much. Q4/2012 results later this month will have more bearing on things I would think. Also Kyprolis clinical data later this year will have real impact on company's potential. One could certainly convince oneself that the price may find support in the high $60s/low $70s.

    Every pharma company claims that building a world class oncology BU is a key part of their strategy so ONXX may be an attractive target. If Takeda was willing to buy Millennium seems likely that someone would look at ONXX.
    Feb 11 05:54 PM | Likes Like |Link to Comment
  • Monthly Trading Of MDY, MVV And UMDD [View instapost]
    Cool. Thanks for your response. Look forward to reading about more of your interesting ideas & backtests.
    Feb 11 04:37 PM | Likes Like |Link to Comment
  • Monthly Trading Of MDY, MVV And UMDD [View instapost]
    Nice work Varan. I am trying to replicate the results just for fun. Do you have any more detailed data? Monthly returns for one of the pair sets would be great.
    Feb 11 04:12 PM | Likes Like |Link to Comment
  • Selling FDA Approvals: Latest Results [View article]
    Agreed - these companies are not usually on the radar of the institutions.
    Dec 19 07:36 PM | Likes Like |Link to Comment
  • Selling FDA Approvals: Latest Results [View article]
    Thanks Michael - I think many readers thought that I had some sort of problem/agenda with a certain company. I am genuinely ambivalent about these stocks. This is purely an observational piece. In fact I am rooting for all of these stocks to take off before approval. Gives them more room to fall thereafter.
    Dec 19 07:29 PM | Likes Like |Link to Comment
  • Selling FDA Approvals: Latest Results [View article]
    Thanks for reading - and for the comment. Like all strategies it does have an associated risk. I would not necessarily recommend this as a stand-alone strategy. When I first looked into it it was really to determine the best time to sell if one were holding through a news release. Given that, I am not sure it is as risky as many plays in the biotech arena given that the position is entered into after the news event and thus after the major price move - and most volatile period.
    Dec 19 07:27 PM | Likes Like |Link to Comment
  • Alexza's Adasuve May Not Be Ready For FDA Approval [View article]
    Something I wonder about is how many of the acutely agitated patients will actually be suitable candidates for this drug. As I understand it, the pivotal studies required patient consent and therefore selected for individuals who could be instructed in how to use the inhaler and who were motivated to comply.

    Many of the patients I have seen with acute agitation presented in the ER in a paranoid, aggressive state or created chaos in hospital wards in the middle of the night throwing furniture through windows. There is just no way that Adasuve would be an option for patients like this.

    The overall market also seems potentially very small. I read a study (admittedly it was a few years old) that claimed there were ~1M ER admissions for psychotic episodes per year in the US. Additional episodes may occur in different settings but the numbers are hardly overwhelming.
    Dec 11 05:38 PM | 1 Like Like |Link to Comment
  • Selling An FDA Approval: Recent Results [View article]
    Perhaps. I did not short it today as it opened so poorly.
    Jun 7 10:41 AM | Likes Like |Link to Comment
  • Selling An FDA Approval: Recent Results [View article]
    Thanks! I personally think that the XNPT window is passed. It is up significantly over the last week (~20% over the week) and is getting pretty close to the PDUFA date now. It may well continue to run but too risky for me.
    May 14 09:31 AM | 1 Like Like |Link to Comment
  • Selling An FDA Approval: Recent Results [View article]
    As I understand it, the FDA cancelled RGEN's meeting because it has decided to issue a CRL on/before the June PDUFA date. The company expects a request for additional clinical data to support the NDA. Given that, if RGEN does end up in front of an advisory committee it will be based on a future NDA resubmission.
    May 12 04:53 PM | Likes Like |Link to Comment
  • Selling An FDA Approval: Recent Results [View article]
    You are quite right. VVUS should in fact be a short on April 30th. Apologies for that - and thanks for picking it up.
    May 10 05:32 PM | Likes Like |Link to Comment
  • Potentially Good Entry Point For Protalix Bio Therapeutics [View article]
    Just thought it would be worth noting the result of this recommendation. The article was published on Feb 22nd. On that day PLX closed at $5.41. The lowest it has been since then was $5.34 on 3/2/12. On 5/2/12 it hit a high of $7.70 before falling off to its current level of ~$6.50. So potential returns of ~20-40% in 2.5 months.
    May 9 10:39 AM | Likes Like |Link to Comment
  • Aria And Talon: Is An Advisory Panel Meeting A Profitable Trading Catalyst? [View article]
    For anyone who is interested, I have published a follow up to this article over at my blog, BinaryLeverage.com - http://bit.ly/GDmfAU
    Mar 21 05:17 PM | Likes Like |Link to Comment
  • Why Pfizer Is One Of The Best Defensive Plays On The Market Today [View article]
    PFE has been a terrible defensive stock in the past so I am not sure why it will be one of the best defensive plays in the future.

    In the past 12 years it has consistently underperformed the market - and this was a period during which it was marketing the most successful drug in history (Lipitor) as well as the most recognised drug in history (Viagra).

    It has a bloated, underachieving R&D department and seems to be completely misguided in its corporate development efforts - rebuilding a consumer health business now having sold its previous business to JNJ at a bargain price.

    Revenue growth is almost impossible to achieve since the existing revenue is so large that there is nothing out there that can move the needle and make up for the Lipitor shortfall.

    You can certainly invest in it for the dividend, but there are better options. Also, how is it paying the dividend? It has a ton of cash, but most of it is trapped overseas and PFE won't repatriate it because it thinks itself above paying tax.
    Mar 20 05:05 PM | 1 Like Like |Link to Comment
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