re: ann: shareholder update In the shareholder update Dr Craven...

re: ann: shareholder update In the shareholder update Dr Craven states:

"at the doses tested XToll has exhibited good tolerability and safety but, so far, insufficient efficacy in the treatment of rheumatoid arthritis. To suggest that a higher dose may be equally well tolerated and show good efficacy is a scientifically unsubstantiated speculation. The effects at higher doses, particularly over 12 weeks of treatment are unknown"

.........."""""HERE IS WHAT THE HEADLINE TRAIL RESUTS STATED"""""" The XToll® 75mg patient group showed statistically significant improvement in ACR-N scores at weeks 8, 10 and 12 compared to placebo. Both XToll® patient groups experienced a statistically significant decrease in swollen joint count at week 12 compared to the placebo group.
o Statistically significant and clinically meaningful improvement in disease activity as defined by ACR-N and SF36 measures (patients vitality and emotional well being) at week 12 in the 75mg patient group.
o Tender Joint Counts (TJC) and Swollen Joint Counts (SJC) were statistically significantly reduced at the week 12 primary endpoint.
o Analyses of a distinct subset of patients in the trial, being those with disease activity duration of =14 years, shows a statistically significant difference between 75mg XToll® patient group and placebo group in ACR20 values (the primary endpoint) at week 12.
Taken together, these findings indicate that XToll® delivered subcutaneously demonstrates signs of clinical effect in patients with rheumatoid arthritis.
? Other trends indicate:
o Patients who continued to receive XToll® in the extension protocol continued to show signs of clinical response for up to 52 weeks.
o Improved Health Assessment Questionnaire (HAQ) scores were recorded in patients treated with 75mg of XToll®.
? Preliminary analysis shows XToll® continues to demonstrate a strong safety profile:
o Overall XToll® was safe and well-tolerated. Injection site reactions tended to be more common in the XToll® patient groups compared to placebo. The majority of injection site reactions were mild in intensity and did not require treatment.
o No additional safety signals were detected in the 52-week extension trial.
? A review indicates that the highest dose, 75mg, used in this trial was a sub-optimal dose and not equivalent to that achieved in the earlier IV studies. This finding supports the need to use higher doses in a dose-ranging study in order to determine the optimal doses of drug...... SO Who is Right HERE? Dr. Craven or the TRAIL RESULTS....Iam CONFUSED CAN SOMEONE HELP...