Replies to post #3167 on Jaguar Health Inc (JAGX)

[TJG]

Results should be completed by the time they have the hearing... all they got back from the Rules Committee was that they were granted a hearing... it should be soon, its done via paper,/ computer or Zoom, not in person... my guess is when they said in the PR they were working diligently on the results, that means they have the results and they are having their people going over how they want to present it to the FDA. This is what actually happens with these trials, company get the results back from the Phase III trial, they then make the decission as to if they want to Un-Blind it or to send it back for reevaluation from the people who did the results gathering... in this case the people at the MD Anderson Cancer Center... If they have chosen to un blind the study then they can not have the results re evaluated... the trial is officially done. When MD Anderson sends it over to them they have given them what they feel in their opinion what the company should do, as they have seen the results and analyzed them. So when she states in the PR they are Diligently working on it, that tells me they have unblinded it and now just have to decide how they will proceed from here.

"We continue to work diligently to complete the comprehensive analysis of the data from our pivotal Phase 3 OnTarget trial of our novel plant-based prescription drug crofelemer for the follow-on indication of the preventative treatment of cancer therapy-related diarrhea." When she uses the word DATA the only way to see the DATA is if thg information is unblinded

These are the people who did the analysis on the Phase III trial when it was completed, both Stage I and Stage II this information is from the U. S Gov't drug trial web site.
https://clinicaltrials.gov/study/NCT04538625

Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Napo Pharmaceuticals, Inc.
Collaborators
No information provided
Investigators
Principal Investigator:Pablo Okhuysen, MD,M.D. Anderson Cancer Center
Study Chair:Pravin Chaturvedi, PhD,Napo Pharmaceuticals