The amount of time they have to return with a response. Any response! Whether it be a yes, no OR----da, da, da, da,---drum roll please---MORE INFORMATION REQUIRED.
I think everyone is getting confused. On February 5th of this year, they filed the IND or hemaxellerate and then on march 18th they received the IND # and questions to be answered. That was a span of 41 days. It has been 32 days from the time they submitted the responses to those questions until now.
This means that the 30 days did not start then they filed it. It is when they receive it. It takes time to send things back and fourth. This goes for the FDA sending their answer back to koos as well.
Don't get all worried that if the 30 days are up it means were are denied but also don't get too certain that if these 30 days are up it means we are approved. The way I see it we still have a most another 10 days of waiting.
Been waiting for this day for 8 months, I'm staying long!
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