Thank you for the info dreamer0. I will keep you and Pete and Here Today posted on my communications with Leo.
Tom
Here is the info... As part of drug development, the FDA allows for potential Expanded Access / Compassionate Use of an Investigational New Drug before any regulatory approval might be achieved. This opportunity applies only to patients with serious or life-threatening conditions who are unable to participate in a clinical trial and have exhausted alternative treatment avenues.
For FDA regulations on Expanded Access / Compassionate Use, please visit the FDA website.
Patients and physicians should refer to the following information before contacting us about potential Expanded Access / Compassionate Use opportunities.
I think that B-OM should qualify because some people cannot complete their Chemo or Radiation regimen due to the severity of the OM. OM is already serious but that makes it life threatening.
Dreamer0 said,
As part of drug development, the FDA allows for potential Expanded Access / Compassionate Use of an Investigational New Drug before any regulatory approval might be achieved. This opportunity applies only to patients with serious or life-threatening conditions who are unable to participate in a clinical trial and have exhausted alternative treatment avenues.