John,
You asked in your post #410 on the Biomatrix thread: What is TMJ? How big is the market (can you post a link)? Have they filed with the FDA already on this?
The following is from an Information Statement, dated 29 April 1993, provided to MedChem shareholders in connection with the spin-off of Anika to MedChem shareholders:
"TMJ dysfunction is a painful condition affecting the joint connection the lower jaw to the cranium, which afflicts millions of people in the United States alone. TMJ dysfunction may develop slowly over a period of years after a jaw injury or may result from personal habits, such as chewing pencils or ice, grinding teeth or clenching the jaw from tension. TMJ dysfunction is a widespread problem that can be segregated into various categories. Among these are: Displace Meniscus with Reduction ("DMN"), characterized by joint pain, limited movement and locking of the jaw. The vast majority of intra-articular TMJ problems tend to be symptomatic of DMR, as opposed to DMN. The exact prevalence of TMJ dysfunction is not known. According to published sources, many studies conducted over the past twenty years have found that sever TMJ problems are most common in women between the ages of 20 and 40. These studies have found that approximately 19% of this female population (or over eight million women in the United States) experience TMJ disorders of varying levels of severity, and approximately 7% (or three million women in the United States) experience disorders sever enough to require treatment. Women over the age of 40 and men constitute additional potential markets for the treatment of TMJ dysfunction. To date, conservative no-surgical treatment of DMR and DMN has been limited to extensive physical therapy, which is frequently unsuccessful. Surgical treatment for sever cases of TMJ dysfunction is complex, traumatic, painful, costly, often unsuccessful and, in some cases, unsafe.. . . . . . . MedChem submitted a PMA application to the FDA in September 1991 based upon the ORTHOVISC study. In December 1992, the FDA accepted for filing Anika's PMA application for ORTHOVISC. Unless additional issues are raised by the FDA during its review of the PMA application and the related clinical data, Anika anticipates that an FDA advisory panel will complete its review of the PMA application by the end of 1993 or early 1994, although Anika cannot predict when the remaining stages of the FDA review process will be completed."
You asked: Lastly, what's your 2 cents on why BIOX has not moved?
My comment: Entire biotech sector is down.
You asked: Do you have any insight as to how well SYNVISC is doing out there in the real world?
My comment: No, but based on what I've read and Biomatrix's sales increases, I think it will do well.
Mike |
