Vivos Inc (RDGL)

[DatMoshu]

From the FAQ. See the bottom of post.

My questions are this:
Are we phase one approved with FDA?
By be in correct clinical trials, does that require already being in human trials or will the pet trials qualify?



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Who qualifies for Right to Try?

To be eligible for Right to Try, a patient must meet the following conditions:

Be diagnosed with a life-threatening disease or condition;Have exhausted approved treatment options;Be unable to participate in a clinical trial involving the eligible investigational drug, as certified by a doctor, who is in good standing with her licensing organization and will not be compensated directly by the manufacturer for so certifying; andGive written informed consentregarding the risks associated with taking the investigational treatment.

What is a life-threatening disease or condition?

Federal law defines a life-threatening disease or condition as: “Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted” (21 CFR 312.81).

 

What drugs or treatments qualify for Right to Try?


The treatments available under the law must meet the following conditions:

Have completed an FDA-approved Phase 1 clinical trial;

Be in an active clinical trial intended to form the basis of an application for approval or be the subject of an application for approval that has been filed with the FDA;

and Be in ongoing active development or production and not discontinued by the manufacturer or placed on clinical hold.