Ann: Lupus clinical trial update, page-4

There are several things which should not be missed. Firstly, my opinion only but supported by some very knowledgeable people, Nadilol is the better property so there should not be too much emphasis on the results of cpN10.
For the last eighteen months, the Company has stated that progress with cpN10 depended on a partnering deal with a major. So the current trial is targeted at the sophisticated people in the pharma industry, not retail investors. These people are largely interested in safety at high doses, and complex data from blood samples, pharmkinetics and pharmadynamics ie what the drug does to the body and what the body does to the drug. We are starting to collect this data for higher doses but have a ten times increase yet to 300 mg. The industry already is very interested in the drug because it is the only RAMP on the horizon and the work in London has excited the industry. Unfortunately, or maybe fortunately, we are governed by the rules of the FDA and they are safety obsessed. The protocols will not allow higher doses until the drug is proved safe at lower doses and will not allow trials in more severe conditions till it is proved safe in mild conditions. All this is frustrating and no doubt the Company feels the same, but that is how me must proceed. To reply to a post on another thread concerning the number of future cohorts, no doubt the Company has applications before the FDA as a result of these results but cannot announce what trials are proposed till they have a response from the FDA.