Was thinking about the Severe phase 2b/3 trial. Th
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Posted On: 08/14/2020 11:19:16 AM
Was thinking about the Severe phase 2b/3 trial. The PE is mortality at 28 days. We are likely to hit the 195 pt halfway mark early next week based on recent enrollment pace (we were at 179 on Aug 7th).
When we hit 195, if we immediately unblind, I would estimate about 150 pts have reached the 28 day endpoint. Of the additional 45 patients, I estimate about 15 might not be at 28 days but we would have met early endpoint data on these patients through hospital discharge (success) or passing away (failure) so we don't need to wait until 28 days for their data. Of the remaining 30, company could could count all leron treated patients as failures (20) and all placebo treated patients as successes (10).
If they run the stats that way and the leron patients still successfully meet the endpoint compared to placebo with p value less than or equal to 0.05, then we could know if the trail is a success next week while waiting for full data at 28 days. Since the PE is mortality, there is no data analysis needed for this. It is known immediately at 28 days. Secondary endpoint would need data analysis which could take a few weeks.
If the PE is hit next week, could it be sent to FDA along with the MtM data to justify EUA as early as by the end of next week?
This is only a theory. I don;t know if it is applicable or correct. I have no idea how data would be reviewed and analyzed during a pandemic. I am happy if others with more experience in this are would comment.
When we hit 195, if we immediately unblind, I would estimate about 150 pts have reached the 28 day endpoint. Of the additional 45 patients, I estimate about 15 might not be at 28 days but we would have met early endpoint data on these patients through hospital discharge (success) or passing away (failure) so we don't need to wait until 28 days for their data. Of the remaining 30, company could could count all leron treated patients as failures (20) and all placebo treated patients as successes (10).
If they run the stats that way and the leron patients still successfully meet the endpoint compared to placebo with p value less than or equal to 0.05, then we could know if the trail is a success next week while waiting for full data at 28 days. Since the PE is mortality, there is no data analysis needed for this. It is known immediately at 28 days. Secondary endpoint would need data analysis which could take a few weeks.
If the PE is hit next week, could it be sent to FDA along with the MtM data to justify EUA as early as by the end of next week?
This is only a theory. I don;t know if it is applicable or correct. I have no idea how data would be reviewed and analyzed during a pandemic. I am happy if others with more experience in this are would comment.
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