Not that my opinion means much(or anything for that matter) but I am less giddy than some here on the US trials and timing. I think the Mexico trial is setting us up for success. 25 patient is all we need? It's like remdesivir for US almost. We're going to approve, just stab a couple obligatory patients and we should be good. For US I think it will be uphill. NP said he stopped having blood samples be sent to Dr BP on the EINDs. We got strung out on the BLA filing...oh you need to include those too, go chase all 800 patients down again to see how they're feeling today. I would not put it past the FDA to day they need to provide data from all trials In a nice format with some mock data for fun.

Not to berade our FDA but I don't think they are treating us different than any of the other 130 indications vying for COVID stardom. So I don't believe they are somehow giving us advice on how to get approval. They seem to send us snail mail letters, to communicate. Not exactly open dialogue. When some thought maybe the FDA wanted us to apply for btd because of our great anecdotal results in a couple cancer patients we got a big no...do it our way, you need preliminary meeting like everyone else.

Not that I want to be cynical, but seeing thoughts of people thinking the FDA is somehow guiding us towards quick approval, seems far fetched based on past history.

However I don't think we will be denied if the data is as good as cydy leadership thinks it is. It just might be a bumpier road than some think.