MSB Trading 2020 - a new dawn, page-7523

Positive or negative?

Personally, I see the announcement as being positive. Why?

A) If the FDA decision was a straightforward approval or rejection, it would be a simple announcement stating such. Did not happen.

B) If it was issued a CRL. Cannot be ruled out, but is not a total disaster. In the short term, yes, but not insurmountable. One would hope that a CRL would not have been left to the last day. (these poor children need a solution now not 6 months to 2 years down the track)

C) Conditional Approval. Highly likely based on previous comments made at the ODAC meeting.

I've ruled out A) and B) for the reasons stated above. This leaves C).

When questioned at the ODAC meeting Fred Grossman openly stated that the company would conduct further trials in adults to allay any fears the FDA had. I believe that the delay until Monday allows MSB to have 2 days to discuss with the FDA the finer details relating to those trials. Some would argue that they've had plenty of time to discuss this, but, until the conditional approval is given nothing can be finalised on those discussions.

Delay due to partnerships has been mentioned. I dismiss that based on why not hit the market with an approval decision followed by a further announcement a couple of days later with a partnership deal? A double whammy which would be a huge boost to the share price. Wouldn't make sense to not do it that way.

I believe Fred Grossman is going to be a very busy man the next few days.

We cannot control any of this, so time to get on with normal daily life until the announcement is made.