What we know so far going into earnings, what we don't know and what I expect at earnings

1. From the communication from the company I believe the following to be true or likely.

a. The FDA is providing a pathway for MF via the Accelerated Approval process

b. The FDA is not going to require a separate confirmatory trial and that the existing Sentry trial will be used as the basis for the transition to full approval.

c. They have had a conversation with the FDA on priority review and the FDA is likely aligned. We have Orphan and Fastrack designations, so likely not a big hurdle.

d. The FDA response indicating confirmation of data to support the filing and conversion protocol still needs to finalized. This appears to be more procedural and routine.

e. The company still plans to file in Aug, but how many timelines have they missed in the last 3 years

f. The company is still in a strategic review with Centerview Partners

g. The executive retention agreement could be used for either acquisition or bankruptcy

2. What we don't know

a. The timeline to become aligned with the FDA to facilitate filing.

b. Where the strategic review process is at because Centerview has been working with them for the last year

3. What I expect at earnings

a. Greater detail on what is left to get the filing submitted

b. Filing date range if known.

c. Statement that they are reviewing strategic alternatives and perhaps set a target date for decision.

I don't think they can have substantial talks on selling the company or raising funds until the FDA sNDA pathway is further clarified.