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.
nexgen is all but complete? So where can we find info on this and what did they change to improve it?
Maybe they changed the formula so that women from the ghetto might actually use it when its prescribed in a clinical trial.
A VERY QUICK REPLY!
Thank you for your note and questions, as they are timely. CBRX has, indeed, completed a complete review of its strategic direction.
The results will become known publicly in the near term. I would invite you to write again once these announcements are in the public domain.
The Company has transferred, according to our contract, ownership of the NDA for Prochieve/Crinone and Watson has indicated its intent to cease pursuit of the FDA's approval.
Continuing discussions are under way.
Needless to say, it serves no purpose to "drive down the market price of CBRX", and we are not seeking to be acquired.
I expect that you and the other shareholders will be provided with company news in the next few weeks.
Thank you for your continuing ownership, I anticipate more positive results as we move forward.