1/
Directly from the horse's mouth :
"Currently, mRNA is considered a gene therapy product by the FDA.
Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not
Directly from the horse's mouth :
"Currently, mRNA is considered a gene therapy product by the FDA.
Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not
2/
to not irreversibly change cell DNA;
however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism.
In addition, because no product in which mRNA is the primary active
to not irreversibly change cell DNA;
however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism.
In addition, because no product in which mRNA is the primary active
3/
active ingredient has been approved, the regulatory pathway for approval is uncertain.
The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different
active ingredient has been approved, the regulatory pathway for approval is uncertain.
The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different
4/
from those required for gene therapy products, or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a
from those required for gene therapy products, or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a
5/
by a regulatory authority varies significantly from one pharmaceutical product to the next, and may be difficult to predict."
sec.gov/Archives/edgar…
by a regulatory authority varies significantly from one pharmaceutical product to the next, and may be difficult to predict."
sec.gov/Archives/edgar…
• • •
Missing some Tweet in this thread? You can try to
force a refresh
