The FDA does not know. The parties that know the most about 2-73's therapeutic effect at the moment are the company and the PI, and likely Ariana (note: not the patients, they do not know all the results). These parties know the 18-month results. And this does not mean they "know" it "works". They just know the results and any signal of efficacy that (hopefully) was discerned.
The FDA gets updates on 2-73 when the company meets with them. They are not waiting with baited breath. That's not the FDA and this is not a fantasy. This is biotech development.
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