Update: I actually wrote to Salpsera (the company based in MN who manufactures Saltikva). They emailed me personally to speak to my sister's oncologist and to contact them. The drug would be available free of charge if all criteria could be met. Compassionate Care Use document was provided to me. Fast track designation and fast track approval was indeed misunderstood, but if more people with this dreaded disease request to participate, perhaps we can make a difference in the availability of this drug.
I only hope the "Compassionate Care" will be extended not only to my sister but to all who can benefit. Nothing would make this year better than to have my sister here as long as possible.