This was the first treatment in pre-clinical trials for BMSN and Regen. The questions are concerning the pre-clinical animal studies. Each time they have more questions, they have to perform more testing on mice. This is the reason that they don't respond in a matter of weeks. It takes a couple of months.
The FDA's job is to be as thorough as possible. This ensures that the treatment does what it's intended to do and with as little possibility for adverse affects.
The FDA doesn't care about time or shareholders, that's not their job. Koos is stuck between a rock and a hard place regarding the FDA, and just like us, he's waiting for the eventual positive approval from the FDA. When all off the questions from the FDA are answered, our day will come.
When you answer questions, usually they lead to other questions.
Others have done it in one month. That's a broad statement, that's dealing with a number of different circumstances. All of the biopics or drugs are used for different reasons, and other companies might have way more experience.
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