This is how I translate NP's FDA's clearance state
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Posted On: 07/17/2019 8:44:36 PM
This is how I translate NP's FDA's clearance statement in my head:
'I estimate the BMC Clinical will be done by end of August. The last time we met with the FDA, they added the 700mg safety data, which added 6 month more time and should be done completed by then. But every time we meet with the FDA, they change the requirements. Assuming they don't adding anything new and allow us just to submit what was requested last time, we should be good to go'
'I estimate the BMC Clinical will be done by end of August. The last time we met with the FDA, they added the 700mg safety data, which added 6 month more time and should be done completed by then. But every time we meet with the FDA, they change the requirements. Assuming they don't adding anything new and allow us just to submit what was requested last time, we should be good to go'
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