Chief...
<The measurement of pain relief (primary variable) reduction of stiffness (secondary variable) and increased flexibility (secondary variable) were all done using the WOMAC methodology..>
I'm not familiar with this WOMAC methodology...will have to talk to a rheumatologist I know about this.
<The design of the trial was discussed, in advance, with the regulatory agencies.>
I was surprised by this. Since then, in performing dd with another company, I have found that Health Canada will, in fact, provide suggestions for the studies and prospective patient numbers, so I have been educated.
<The analysis, conducted for us by the Robarts Institute in London, concluded that only PENNSAID provided statistically significant benefits in either the primary or secondary variables>
I'm not sure of this business with the "Robarts Institute"...don't know who they are...however, any statistician, especially one familiar with clinical trials could have performed this analysis.
<In fact, you could argue that a small sample size can present a huge obstacle to a Company as any one patient that does not show benefit with the drug can skew the results quite significantly>
Actually, this is quite true...while small trials need confirmation to identify whether the results were true, the fact is, one can get any result if the trial and patient population are big enough. The fact that a small trial can show a result may be significant.
<For now, we would point out that all three agencies (FDA; MCA; HPB) have accepted our submission for review.>
DMX has been stating this all along and unless someone's misrepresenting themselves, this is a big positive. If there are deficiencies in testing, production, the agencies will notify the company. Whether the company provides disclosure to the shareholder, and in a timely fashion, is another thing.
Hope this helps.
Sorry again for the length...
Regards
Jeff C |
