FDA Application for Orphan Drug Designation , PAA, MPL

Thought it best to look at the coming months ahead , MT has stated once the MND Data is compiled there will be a rapid application for FDA ODD.

This is a great research tool from the FDA , FAQ number 6 has a video about the application process
https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/frequently-asked-questions-faq-about-designating-orphan-product

What I did find interesting is there is a considerable amount of ODD applications that only have animal data, so with the amount of Human MND Data ODD for the Treatment of MND does look highly likely.

Patient Safety is the FDA primary concern then Benefits of Treatment...

The FDA ODD process is regulated to 90 days and being the FDA that means 90 days.. so upon PAA announcing it has applied for ODD the timeline is 3 months until a decision is made.

Many are familiar with the benefits of ODD
7 Years market exclusivity
$2m USD in Credits
Patients can claim back medication expenses
Treatment is recognised by INSURERS , etc

This site provides great detail

Introduction to the Office of Orphan Products Development ...

Food and Drug Administration (.gov)

https://www.fda.gov› media › download

Orphan Drug Designation &Exclusivity. • Goal: Stimulate development of drugs ... incentives (taxcredit, waiver of user fee,7-yearexclusivity).DESIGNATION.

What does ODD do for the Company , in the last couple of months I have watched one company Double their SP on the run up toward FDA approval.

For the company , over the past 3 months I watched a company double their SP during the FDA Application Period ...

There are specific USA Legal Firms that carry out the ODD FDA application Process so well worth contracting those that carry out the task every week.. NZT