AGM Discussion, page-102

I think with Ryoncil, they didn’t go early... they turned up in business casual clothing when the agency said black tie!

In terms of the COVID trial... it’s a totally different review team that they will be deal with. One that is well aware of the pandemic and the urgent need for a reliable and effective therapeutic.

So there is definitely merit in meeting with them before this final interim analysis, which is what I think is going to happen. This would explain why Silvui has been reluctant on giving any guidance on the timing of when the final interim read-out will readout. Because if the recommendation is for an early stop and the meeting with the FDA hasn’t occurred yet or there needs to be a follow up meeting... then IMO the read out will be delayed until those meetings have been had and MSB is happy with the outcome and will agree to stop the trial early.

But I think in the grand scheme of things, we are really splitting hairs on when this trial will read out.. it’s either in Dec20 or Feb/Mar21. I can’t see it getting delayed any further than that.

I guess the point I’m trying to make is that if the trial were to be stopped early, we can safely assume the FDA as effectively given a green light to an EUA and that will only be a formality.

I think management have learnt a tough lesson with the Ryoncil, and it’s better they go through this early in their corporate life and on a smaller indication such as this. We will be better off in the long run because of this saga.