David PS
Member
David's Sinclair has spoken about a new NMN pharmaceutical under development (MIB-626). Incidently, David is a co-founder of Metro International Biotech
In addition, David is a named inventor on the US patent application assigned to Metro.
The two relevant documents describing the FDA's justification are at this deep link to the relevant page:
From the end of the second and most recent document (supplemental response letter)
Metro Biotech Publishes MIB-626 NMN Human Data
A study published by a research team from Metro International Biotech and Harvard Medical School shows that a pharmaceutical-grade preparation of NMN known as MIB-626 increases blood levels of NAD+ in one week in middle-aged and older adults.
www.nmn.com
In addition, David is a named inventor on the US patent application assigned to Metro.
The two relevant documents describing the FDA's justification are at this deep link to the relevant page:
Regulations.gov
www.regulations.gov
3. Conclusions
After evidence that is irrelevant under section 201(ff)(3)(B) for the reasons discussed above has been eliminated, two possible dates of first marketing for NMN are left:
February 16, 2021 – First date on which another notifier could have marketed its NMNcontaining dietary supplement lawfully after submitting an NDI notification to FDA on December 3, 2020; however, it is unclear whether NMN was actually marketed on that date.
September 2021 – Month during which Kingdomway first marketed Doctor’s Best Instant Whey Protein Concentrate Plus NMN as a conventional food. Both of these dates are after the first date on which NMN was authorized for investigation as a new drug.24 Accordingly, we reaffirm our earlier conclusion that NMN is excluded from the dietary supplement definition under 21 U.S.C. § 321(ff)(3)(B)(ii) and may not be marketed as or in a dietary supplement. Today we are sending letters communicating this conclusion simultaneously to all firms that have submitted an NDI notification for NMN.:
Last edited: