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  • MELA August FDA Panel Creates Run-Up Opportunity

    Mela Sciences today announced a U.S. Food and Drug Administration panel will review its computer-assisted cancer screener for pre-market approval on Aug. 26. In March, the agency extended what had been an expedited review because of questions about the device, called MelaFind, which consists of a handheld imaging “gun” that emits wavelengths of light to capture images of suspect pigmented skin lesions.  The FDA indicated that the MelaFind PMA review had been extended 180 days.

    Included in their PR today MELA reported the results of its internet-based US reader study performed by 155 physicians, including 110 dermatologists, on images and clinical information derived from 130 lesions (melanomas and non-melanomas) enrolled in the MelaFind pivotal trial. The average sensitivity of dermatologists was 72%. The sensitivity of MelaFind was 96.9%, which was statistically significantly superior to dermatologists at p-value of less than 0.0001. The Company plans to submit the results of the reader study to a peer review journal for publication.

    As recently as January of this year MELA was trading over $12 per share.  Take a look at the chart:

    Hopefully MELA will duplicate its recent run to the $12 range before its FDA Panel.  Today, 3 months out from the panel, the stock has risen over 27% on this news.  My strategy is to wait until the initial buying pressure decreases before opening a position.  I will likely roll the funds I have in CXM (6/3 510k) and PGNX (6/4 sNDA) into MELA in early June to play the run-up to the panel.


    No position

    See my website at for more trading information and daily updates to the free, no registration, FDA calendar.  Make sure to sign up for the spam-free email updates through Google's FeedBurner. Enjoy.


    Disclosure: No position
    Tags: MELA, Biotech
    May 26 2:51 PM | Link | Comment!
  • Using Twitter for Biotech Trading
    When I first hear about Twitter a while back, I have to admit, I thought it was worthless.  Really, who cares enough to track celebrities every move?  And who is so self absorbed that they will take the time to tweet where they are eating or what they are doing?


    However, I have found a great and worthwhile use for Twitter:  Stock trading.  Where else can you get free, up to the second updates from multiple respected members of the trading community, all in one place? It is a very valuable tool to add to your trading toolbox.

    If you do not already have one I recommend going to Twitter and signing up for an account.  Here are a list of users that I highly recommend following:

    BioRunUp  obviously :)


    You can also download free Twitter applications that will auomatically update your smartphone with the tweets of those you follow.   I use UberTwitter for  my BlackBerry, and I would recommend it.

    See my website at for more trading information and daily updates to the free, no registration, FDA calendar.  Make sure to sign up for the spam-free email updates through Google's FeedBurner. Enjoy.


    May 25 2:17 PM | Link | 1 Comment
  • ALXA - Potential For A Run-Up (FDA Catalyst on 10/11/10)

    Another promising run-up play for October is Alexa Pharmaceuticals and its lead candidate AZ-004, which is an inhalation product candidate for the rapid treatment of agitation in patients with schizophrenia or bi-polar disorder.  It has a PDUFA date of October 11th, 2010.

    Let’s take a look at the chart for ALXA over the past few months:


    It is clear to see that a nice run-up is developing.  Let’s take a look at Alexza and it’s pipeline of products.

    About Alexza

    Alexza Pharmaceuticals is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexza’s technology, the Staccato(NYSE:R) system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation. The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience.

    AZ-004 (Staccato loxapine) is Alexza’s lead program, which is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients. Alexza has completed and announced positive results from both of its AZ-004 Phase 3 clinical trials, submitted a New Drug Application submission in December 2009, and has a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010. In February 2010, Alexza established a partnership with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, to develop and commercialize AZ-004 in the U.S. and Canada.

    Alexza has completed an end-of-Phase 2 meeting with the FDA for AZ-001 (Staccatoprochlorperazine) and has completed two Phase 2 studies with AZ-104 (Staccatoloxapine, low-dose). Both product candidates are being developed for the acute treatment of migraine headache.

    AZ-002 (Staccato alprazolam) has completed Phase 1 testing and one Phase 2a proof-of-concept clinical trial. Product candidates that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain, and AZ-007 (Staccatozaleplon) for the treatment of insomnia. More information, including this and past press releases from Alexza, is available online at


    From Alexza’s most recent 10-Q filing with the SEC (5/10/10)

    As of March 31, 2010, we had $41.0 million in cash, cash equivalents and marketable securities. In May 2010, we borrowed an additional $15 million. Our cash and marketable securities balances are held in a variety of interest bearing instruments, including obligations of U.S. government agencies, high credit rating corporate borrowers and money market accounts. Cash in excess of immediate requirements is invested with regard to liquidity and capital preservation….

    We believe that with current cash, cash equivalents and marketable securities along with interest earned thereon, borrowings under the Hercules loan agreement, the proceeds from option exercises and purchases of common stock pursuant to our Employee Stock Purchase Plan, we will be able to maintain our currently planned operations through the second quarter of 2011 and will extend into 2012 if we achieve the eligible milestones under the Biovail collaboration during the next 12 months. Changing circumstances may cause us to consume capital significantly faster or slower than we currently anticipate. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available financial resources sooner than we currently expect.

    Trading Method

    ALXA seems to be another perfect candidate for the run-up method.  I already have a small position, however I look to increase my holdings as we get closer to July-August.  My target run-up price for ALXA is $8 per share.  Before a series of dilutions ALXA was trading at nearly $13 a share when it announced its positive results from the Phase 2b study of AZ-004.   My advice on this one is to get in early and hold until a few weeks out from the FDA date.



    Long ALXA

    See my website at for more trading information and daily updates to the free, no registration, FDA calendar.  Make sure to sign up for the spam-free email updates through Google's FeedBurner. 

    Disclosure: long ALXA
    Tags: ALXA
    May 17 2:13 PM | Link | 1 Comment
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