To: Mark Bartlett who wrote (4134 ) 4/16/2000 10:26:00 AM From: DaveAu Read Replies (1) | Respond to of 14101
Here's my E-mail to Peter Block yesterday and his response. He must have his E-mail forwarded to his home. The time on the response is 23:46. > Hi Peter, > > A few questions on current status. > > 1. Has the final British approval of Pennsaid been received? If not, can > you tell if and when Dimethaid responded to the concerns about labelling > etc. > 2. Have any applications been filed yet for the other European countries > ? If so, when? If not, can you estimate when such filings will be done. > 3. Has the FDA inspection of the manufacturing facility been scheduled > yet ? > 4. Can you help me understand the recent WF10 results. Was this looking > at blinded data ? Is there historical data that would help me understand > what number of deaths or SAEs are to be expected in patients with AIDS > this far advanced ? When will there be interim results to report on > efficacy ? > > Thanks for your time. I will post your answers on SI which hopefully > cuts down the number of times you have to answer the same questions. > > Dave Hi Dave, Let me deal with your questions in order: We will announce when final approval of PENNSAID(r) has been received anywhere, including the UK. We do not believe it will be much longer before everything is in order with the British which will then lead to other European regulatory submissions. We have also been continuing our work with the FDA. Again, as soon as there is something formally communicated from them, we will also announce that. In working with McNeil Consumer Healthcare (J&J), their advice is that we not comment on ongoing developments with the FDA but instead only report on formal developments. Given their experience in dealing with the FDA, we think it is good advice. The data presented at the Salvage Therapy Conference in Chicago on WF10 was strictly related to safety. Earlier studies with WF10 have certainly suggested efficacy, but because the blinding has not been broken on this trial, it is unknown at this point what those results would be. I don't think there is an "expected" number of SAEs or deaths that can be used as a benchmark other than to quote the abstract where it indicates that patients with CD4 counts below 50 are at great risk. The timing of the release of any efficacy data is difficult to predict as there are a number of variables at play. Certainly, the randomisation of the remaining patients and a follow-up review of those patients is a likely step before any final analysis can be presented. Sincerely, Peter Block Director, Corporate Communications