Frequently Asked Questions
How can I get access to the drug?
Patients may potentially gain access to an investigational therapy three ways: through clinical trials, expanded access programs (EAPs), and single patient access or emergency use. For most patients, the only way to access to the therapy is to participate in a clinical trial. However, patients with serious or life-threatening or advanced stage of the disease may not be eligible or able to participate in clinical trials. In these situations – and when other essential criteria are met – patients may have access to the investigational therapy through expanded access programs (EAPs) or single patient access (including emergency use).
If you are interested, please send us a note or have your neurologist contact us so we can place you into our data base.
When will the clinical trial begin?
This is determined by the FDA and we estimate it to be sometime Q4 2018 to Q1 2019
What criteria do you use to select a patient for a clinical trial ?
New Biotic, Inc. works with medical and scientific experts, as well as regulatory authorities to develop the protocol for a clinical trial, which includes the eligibility criteria. Patients must meet these eligibility criteria before they can participate in the trial
The principal investigator or study doctor screens and determines whether a patient meets the eligibility criteria
Patients must be informed of any potential risks and benefits of such an investigative therapy. Eligible patients must sign an informed consent should they decide to participate in the trial