2 patients just seems a little too low. I would as
Post# of 154479
(Total Views: 400)
Posted On: 01/08/2020 9:35:51 AM
2 patients just seems a little too low. I would assume the FDA would want more data and I've read a few times it takes about 5 patients, but I hope I'm wrong. Just seems too optimistic to be able to file it by end of this month. If we file this month great but if we file by March I'm still fine with that and would rather file later with more data to make it less likely to get rejected.
The FDA is already giving us a hard time, imagine if our safety data wasn't as good as it is? The FDA would have delayed us even more.
The FDA is already giving us a hard time, imagine if our safety data wasn't as good as it is? The FDA would have delayed us even more.
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