What are people's thoughts around the issue of statistical significance for this trial?
The primary endpoints are safety and PK (which I believe will be fine) with various secondary efficacy endpoints for the purpose of selection of appropriate endpoints for a Ph3 trial. With only n = 20, there is a good chance some efficacy endpoints may not reach p<0.05. Given the stated aims of the trial, this in itself is not necessarily an issue and I believe was the case for at least some of the efficacy endpoints in the Rett Ph2 trial.
However, I can see that some may use this to argue the trial has failed, when in reality it is just a power issue. Be interested in the views of anyone in the trials space or who can recall how the Rett Ph2 trial played out.
Ann: Neuren completes Phelan-McDermid syndrome Phase 2 trial, page-43
Add NEU (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
$19.97 |
Change
0.000(0.00%) |
Mkt cap ! $2.552B | |||
| Open | High | Low | Value | Volume |
| $19.96 | $19.97 | $19.69 | $4.156M | 209.6K |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 246 | $19.88 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $19.99 | 512 | 1 |
View Market Depth
| Last trade - 16.10pm 05/07/2024 (20 minute delay) ? |
| NEU (ASX) Chart |