MSB Trading 2020 - a new dawn, page-7597

@flyingmango I agree a CRL is a very bad result, but it is also dependent on what the letter says. If it just a query to confirm a manufacturing technique, or batch consistency query, then this could hopefully be answered relatively quickly and approval could therefore be still a matter of weeks away.

@Thomas20 - I cannot see how a CRL could take 5 years to resolve. A CRL cannot say do another two trials etc, I believe it's more issues that need to be resolved around data/manufacturing etc. More likely it will be something that may be able to be resolved in 1-3 months, but I don't think it will be unresolvable. That will be like a quasi-rejection, which won't happen with a 9-1 approval, and kids in danger.

I think it is a matter of perspective. If approval is delayed by a month, yes the month will be the longest and hardest for us shareholders, but in two years time it will be a blip on the radar and just one of those falls we see on charts of companies that are funny to look at (i.e. ODAC blip).

I personally do not think a CRL is what is happening BTW, but rather MSB and FDA are meeting to discuss parameters on the confirmatory trial for pediatric and setting up a stage 3/4 for adults.