Ann: Change of Director's Interest Notice - Silviu Itescu, page-133

"compassionate use program does prove the Physicians using it believe it does works"

No, it doesn't.

"FDA do not consider it blatantly unsafe"

Correct, which is why the "Physicians" use it.

"nor there any decent alternative for its patients to use"

Correct, which is why the "Physicians" use it.

From the FDA itself:

"Investigational drugs, biologics or medical devices have not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects."

It's FDA arse covering, but it still means what it says.