Relief Therapeutics Holding AG (RLFTF)

[changes_iv]

MEDICAL COUNTERMEASURES, or MCMs, are FDA-regulated products (biologics, drugs, devices) that may be used in the event of a potential public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, or a naturally occurring emerging disease.

https://www.fda.gov/emergency-preparedness-and-response/about-mcmi/what-are-medical-countermeasures

ARE GLOBAL COUNTERMEASURES THE BADDIES??? ———
Because of its lack of toxicity and low cost of manufacture compared to proprietary biologics, VIP may be uniquely attractive to those focused on global countermeasures against COVID-19, says the company. ———
VIP is known to target the VPAC1 receptor of the alveolar type II (ATII) cell and protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. In addition, VIP prevents apoptosis, blocks cytokines, lowers TNFa levels, reverses CD4/CD8 ratio, and reduces cough and dyspnea in nonclinical and clinical studies.

https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic

IV. EMERGENCY USE OF ELIGIBLE FDA-APPROVED MCMs WITHOUT AN EUA ———

Section 564A allows FDA to facilitate certain emergency activities involving FDA-approved MCMs without an EUA. This authority is independent of the EUA authority under section 564. In the past, to address concerns about potential FD&C Act violations related to the activities discussed in this section involving MCMs, FDA has either: (1) exercised its enforcement discretion with respect to the activity; or (2) issued an EUA to ensure that use of such MCMs remains covered under any otherwise applicable protections under the PREP Act61 (discussed in section VII of this guidance). MCMs used under this authority qualify for applicable PREP Act protection.62 ———

In some cases, FDA and CDC may coordinate activities under section 564A authorities including the issuance of an emergency dispensing order, waiver of cGMPs, waiver of REMS, extension of expiration dating, and/or issuance of EUI for specific MCMs.63

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities