To: opalapril who wrote (8353 ) 1/18/1999 11:16:00 AM From: aknahow Read Replies (1) | Respond to of 17367
Opala, from the start, shareholders were told that they could not be informed of trial deaths. This was unusual, and caused speculation at the time. The, "triggering source," as you call it was XOMA. Murphy then confirmed the need for a specific number. I doubt Murphy knew way back when, and in any event everyone felt the trial would end in Dec. There were other reasons to sell, i.e. the floorless convertible, other opportunities and Murphys own scale back in letter portfolios to fewer companies. The trial was firt considered a two year trial, then it became apparent that the reasonable target for accruals was 200, when the U.K. was added and with the epidemic nature of the disease in the 1 st. quarter it was clear 200 would be surpassed. So, if total deaths were a target, and progress towards this target could not be discussed, nor indeed the specific number required it can be understood that there may have seemed no need to even disclose that a specific number was being looked for since it seemed it would be reached by the end of Dec. When it became apparent that it was not being reached XOMA mentioned the possibility of continuance in conjunction with a DSMB review. It became difficult for shareholders to understand the reason for continuance and it seemed as though the only reason the trial could be continued was due to lower than expected efficacy and or a lower death rate in the placebo group requiring a greater number of subjects to obtain a significant level of confidence in the results. So while XOMA had kept to the mandate and not disclosed the actual target, nor total deaths the fact that total deaths, the sum of both legs of the trial are critical to terminating the trial has been disclosed. As Gonzalez stated, one can call XOMA. The above represents a scenario only, of one possible explanation of why if one believed the trial would end within the timeframe one had provided, no additional details would have seemed necessary and how when it became apparent that this was not correct additional information would be provided. As Bob says, the above is for entertainment purposes only. I am not privy to how or why XOMA, the FDA, the DSMB or RobertK makes decisions. I construct what if scenarios, knowing from laying of the first block that 99.9% of what I construct is not true and that the .1% that is true cannot be recognized by me for any useful purpose. <g>