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Columbia Laboratories, Inc. Message Board

  • koleminer1 koleminer1 Jan 15, 2013 4:23 PM Flag

    Note to Kasnet

    Dear Mr. Kasnet,

    You and I have exchanged correspondence before (please see below regarding Sebelius and NDA 22-139) and I am hopeful that such candid and fruitful discussions will continue regarding the issues below.

    I. New FDA Approval Pathways

    In the event that you are not already aware, I bring to your attention a fairly recent development with the FDA. As per Docket FDA-2012-N-1248, “Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need”, the FDA will be holding public hearings. More information may be found in the attached PDF. Registration is required by January 22 and I would strongly urge Columbia and Watson to fully exploit any opportunities.

    II. Concerns over Share Price and Corporate Direction

    With regard to my second matter, I imagine that you are as disappointed as most shareholders with the unfortunate series of events regarding the clinical trials and the FDA’s consideration of Prochieve. I don’t wish to dwell on this but am of the opinion that the current share price is a travesty given: sales of Crinone, off-label use of Prochieve, available Net Operating Losses and cash on hand. The silence of management and the board of directors is difficult to accept as the share price drifts. Is the share price truly reflective of the skills and interest of senior management and the board of directors? I hope not. So, on this basis I have several comments/questions:

    a) Several months ago, Columbia Laboratories initiated a strategic review of operations. When will the results be announced, or why is there no further comment? Or, on the other hand, is part of the strategy to drive the share price so low so that the company becomes an easy acquisition target?
    b) The publicity coming from Columbia Laboratories is very weak, in my opinion. A new January 2013 presentation has been prepared; when will the board and senior management become more aggressive in “telling the CBRX story”?
    c) When can we expect to learn of any developments with regard to the next generation of Prochieve?
    d) With the cash available, why has a share buy-back program not been initiated?
    e) When are we going to get some good news?

    I would appreciate any tangible (not “motherhood”) comments that would provide the confidence necessary to continue to be a shareholder.

    Thank you for your kind interest and attention to this matter.

    Sincerely,

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