Cell Therapy News/Articles, page-17797

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/off-label-unproven-specialty-drug-treatment.pdf

This link is for a US health care provider- policies re OFF LABEL use- great reading for the brains trust.

If approved for pediatric then off label to adults is a possibility regardless of a trial is my take on reading this document- although this excerpt needs consideration- Off-label use is further defined as giving the drug in a way that deviates significantly from the labeled prescribing information for a particular indication. Is adult use a significant deviation?
If LVAD receives accelerated approval then significant deviation for MACE events over GI bleeds is most apparent and sales potential will be massive



Another excerpt below stating laws differ between states:
If the coverage review using the NCCN Compendium determines that the drug is unproven, then further review is indicated.
Some Certificates of Coverage allow for coverage of experimental/investigational/unproven treatments for life-threatening
illnesses when certain conditions are met. The member specific benefit plan document must be consulted to make coverage
decisions for this service. Some states mandate benefit coverage for off-label use of medications for some diagnoses or under
some circumstances when certain conditions are met. Some states also mandate usage of other Compendium references.
Where such mandates apply, they supersede language in the benefit document or in the medical or drug policy. Benefit
coverage for an otherwise unproven service for the treatment of serious rare diseases may occur when certain conditions are
met. Refer to the Policy and Procedure addressing the treatment of serious rare diseases.


Numbers are being run on stock price potential if we are fortunate to receive approval for Ryoncil in pediatric SR aGvHD- imo not enough focus is being placed on off label sales for both Ryoncil and Revascor.


Please let us have an announcement today_ I can't handle the " are we there yet" commentary.


GLTALTH


Reg