I'm new to this thread and to DMX, as a shareholder...
I've finally had a chance to get some information from Peter. I haven't, however, had a chance to discuss the information that I've received, with him. One thing that I can say is that I haven't been particularly impressed with the studies that have been performed to date. Two of these studies are in a somewhat obscure journal called "Pharmaceutical Research" as opposed to, say something like the "New England Journal of Medicine". Since I do not have access to this journal, Peter has indicated that he will provide the references for me. As a result, I can't really comment on them.
Another was a comparative study against placebo and a control group (using the same pharmaceutical vehicle as Pennsaid...not sure if this study has even been published). Although the Pennsaid group appeared to have a "statistical significance", I couldn't really judge the study because only the results and not the methodology were provided to me. In addition, the number of patients studied was a small number (n=159). Compare this to a recently released drug to prevent heart attacks, Plavix, in which their pivotal study had over 19,000 patients.
Now, I realize that Pennsaid uses a NSAID whose patent protection has expired,(namely diclofenac), but in order to get attention and quick action from the regulatory bodies, companies are now starting to use larger patient populations in their studies, and, in some cases will actually test their therapy against the current standards of therapy...sort of putting your money where your mouth is. At this point, I haven't seen any evidence that much money has been spent on randomized, comparative, clinical trials using Pennsaid against other forms of NSAID therapy. As I've stated in a previous post, I performed a medline search using the search term "diclofenac", looked at 400 citations without seeing anything reference to DMX's product. I finally gave up.
Maybe I'm way off base here, however, I've been in the pharmaceutical field for over 15 years. In my position, I have responsibility for reviewing data for drugs that companies wish us to use. I have not seen the same breadth of data from DMX.
I don't know when the submissions were made. The wheels of bureaucracy turn slowly anyway. Maybe, however, it is this lack of clinical data which is causing the delay.
...my 2 cents worth...
Regards,
Jeff |
