MSB Trading - 2020, page-1738

I picked this up on one of the sites which is quite interesting:

"Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients."

There are 2 factors which one has to consider:
1. The treatment has been proven in Japan where it is already be approved for a couple of years now and as there has been no adverse repots on its effectiveness, this should auger an earlier approval.
2. I remember in a conversation sometime ago with Ross Macdonald and his view that the the effectiveness of such treatment will be known after 28 day from initial treatment, hence the period is pretty short and the trials run by MSB have statistical evidence to back this up.

Hence I am pretty sure that as a consequence of frequency of communications and I am making an assumption that MSB has had a number of such dialogues with FDA and the Prof's tone of his communication which is positive and most encouraging, we could well see an earlier approval perhaps by early/ mid March. This is of course my uneducated view but I think there is some merit in it.