Replies to post #46304 on OncoSec Medical Inc (ONCSQ)

[dangerM]

Ultimately yes, the changes in design and when everything is done even the results of the trial will have to be recorded on ClinicalTrials.gov!

To my understanding, however, there's quite a bit todo before such a change can be made. Besides formulating an updated so called statistical analysis plan they'll have to get some new ethics board approval for the higher number of patients to be enrolled and possibly more.

Given the above (and more) formal activities that have to be implemented, IMHO it's quite normal that the entry on ClinicalTrials.gov doesn't reflect a change yet. Still I am not completely certain if such an update is mandated within 30 calendar days or only within the yearly update cycle, so I had to ask, see here

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146570751


I wouldn't care so much on the entry in the trials registry, but rather communication with the FDA and when they formally have made the design change. It may seem irrelevant to us, but they are in the situation of seeing more and more of the results which in turn might introduce a bias.

See for example section "8.1.2 Reviewing Changes to the Statistical Analysis Plan" in https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM377108.pdf or (even if this is for devices) p. 18 Sample Size Reassessment in https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm446729.pdf

> I wonder why they were not stressing the point that the subjects on the study were those who had already failed every other treatment.

This is what everybody wonders about.

Perhaps they were somewhat to optimistic first and then did not know how to change the spin without letting the share price crater.

Probably Alpha Holdings is also very interested in the answer.