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More RSV news coming According to the data sheet describing the RSV P3 trial, the first read was scheduled at 45 cases of RSV, the second read at 75 cases and the final read at 106 cases out of 37,000 participants in the trial being conducted in 22 countries. The news we got on 1/17 (the first read) was based on 64 confirmed cases with 2 or more symptoms. That's only 11 short of 75 needed for the second read. I don't know why they waited for 64 cases were used when 45 was the target. Could it be that the trial is so dispersed that by the time they knew they had 45 confirmed they really had 64? Don't know and really don't care. If 75 really is the next read, that may come soon. Nevertheless, how much more statistical significance can be gained with just 11 more cases? Don't know that either. We also don't know the time it took between the first case and the 64th. Despite all the stuff I don't know, I'm confident they do know. I'll just wait but won't be surprised if more news comes sooner than might be expected. Of course I expect an announcement of filing with FDA and maybe another upon FDA acceptance with priority status. |
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