There is no specific timeline because it depends on when the biotech company approaches the FDA for guidance. IMO, there is a strategy involved.
You see, if a company can release their data at a prestigious event (like CTAD), and get rave reviews from their peers...it's my opinion that the FDA will be much more lenient with their guidance.
Of course, if the data isn't that good this strategy can backfire on the biotech company too. Getting bad reviews from your peers will most likely cause the FDA to be more stringent. (This is all my opinion of course)
Here's the bottom line...if you have great data, you want to show it off at the most prominent conference in the world before you present it to the FDA.
The accolades are almost certain to influence the FDA in your favor.
TGD knows what he's doing. History is about to be made...and we, as investors, are going to be a part of it!
God bless all us for our patience.
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