LL's CoV trial data failed to meet ALL their protocol endpoints. Post-hoc subgroup analyses are viable for any approval consideration in a trial that failed to meet its endpoints. In fact, the critical data was from a sample so small that the data was not statistically significant using the proper statistical methodology. It is on useful to inform future trials, but not for any approval consideration.
We'll see if any of the current trials meet an endpoint. The Brazilian trial may only be useable for exU.S. regulatory consideration. NP chose not to file an FDA IND or get an FDA audit that normally is required to make an exU.S. trial acceptable for U.S. consideration.
Unfortunately this CD10/CD12 failure caused a significant delay and now any trial success may have nominal value for shareholders.
HIV BLA is going to continue being very slow which, which will give Gilead's capsid inhibitor time to get to market and with the large Gilead sales force and it's advantages will be hard for Regnum (staff of 2) to compete with. Not much of a competition.
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