Hey RA , not a great deal other than DB said the CD FDA approval is complex and long winded , they mentioned that the software and Hardware had been updated and that they had been at it a year , hence why Iput the tracker link down on the other CD thread . average time is 245 days for anesthesiology devices.
On the BPH he stated, when I asked about the extra information, That ASX determined the publishing content of any announcements, so some updates were not always newsworthy in their eyes ... so they may or may not have submitted the new information
When I asked him what the prognosis was with BPH , he said it was all about the supply of gas, and that was the main driver he could see as approval gets closer.
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