there's a ton of work required to validate systems and all clinical trial results, animal study data (see ARNA), commercial/manufacturing, they have to prove their manufacturing processes are good, replicatable, in compliance, they have to get everything right the first time, or run the risk of FDelays. Yes, it should be simpeler and faster, but it's not. Biotech investing is very complex, you will learn over time and likely by losing a few times before winning and most of us have. All IMO.
It usually takes this long to enable congressional members to load up bfr. they GAIN approval especially after just voting down the STOCK act, There are too many congressional trades to fit in the queue till the next Q.