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  • ricardouno ricardouno Feb 5, 2013 12:11 PM Flag

    Ricardo - CLDX


    I view these developments as positive.

    I think CLDX is doing the right things at the right time here, given the early results of their CDX-011 study.

    Here is what makes sense to me:

    1) Trying to pursue Accelerated Approval which is the quickest and least costly way to get this particular product to market ( that is, of course, if the drug "works" )....and having careful input and guidance, prior to final study design, from the FDA.

    2) Trying to seek equity funding, to help finance a potentially pivotal registrational study rather than partnering right now from a position of relative weakness and relinquish a large measure of future control of the product.

    The fact that a partner was not announced presently, has no bearing in my investment thesis at this time. Even if the company was approached, I feel that equity financing is a much better strategy selection at this juncture.

    Frankly, it all comes down to whether this drug "works". I am "reasonably" confident that, in a properly designed larger study, the drug will "likely" show benefit in GPNMB highly positive ( 25% or greater ) and triple neg breast cancer patients. It would be nice if they could also show benefit in larger subsets of triple neg disease as well.

    I personally rate CLDX a hold and have a significant position in the shares......although not nearly as large as my SGEN long term position.

    The above is only my PERSONAL opinion. Do NOT take it to the bank. Each investor must make the decision on whether to buy, sell or hold by themselves. Investing in early stage biotech involves considerable risk. Caveat emptor !!

    Good luck!


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