Jaguar Health Inc (JAGX)

[TJG]

I would suggest that those interested read this FDA page on drug approval... Pay attention to the section about how a drug can be accelerated through the process. A drug that helps a life threatening disease and there is no other drug on the market like or similar will qualify for this exception. A drug that has benifit for HIV is classified for this exception.... JAGUAR HIV Crofelemer was granted this exception. Its pretty safe to assume that this version of Crofelemer will also qualify, because there is NO current drug to effectively treat the side effects of chemo when it comes to diarrhea and that a factual study show 4 out of 10 discontinue treatment due to the effects of diarrhea. Now Lisa is not going to talk about any of these options because there is no guarantee they will get the waiver. But you can bet its part of the process that Jaguar will use when they submit the drug. You are all getting way to caught up in the presentation of this at some conference that has no real baring on getting this to the public. Telling your pears at a conference about what you have done is nice but it wont sway the FDA or help the bottom line. Many of us believe they have the results and know the Phase III results are positive. They have the NDA (New Drug Application) ready to go, its a form and a process that can be done and needs to be submitted. They will do the RS they will submit the NDA and sometime be fore the end of the year they will have approval... They also will announce a U.S distributor who has FDA approval for manufacturing approved drugs and that will speed up the FDA approval of the manufacture having their site approved, as stated in the link below. This whole delay is simply a fall back to the RS incase its needed.

https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-continued