Regarding the timeline:
It should be noted that Frequency Therapeutics dosed their first patient with FX-322 in a clinical trial in 2017. Based on research I shared a few pages back, the average expectation of a drug gaining final FDA approval from first dosing is 9 years.
Which would mean 2026.
FX-332 received Fast Track, which lowers the estimate to 7 years: 2024.
IF Breakthrough Designation, they may get it to 5 years, or 2022.
Based on the plans disclosed thus far by Frequency Therapeutics to end 3 trials in 2021, and speculation that a pivotal trial may take place in 2022; it's likely they are beating the average Fast Track duration, with an FDA approval possible in 2023.
The one IF that might get the drug released early is the FDA Breakthrough Therapy designation. If all of these 3 trials end with significant improvements and favorable safety, I don't see why it wouldn't get the designation. Based on my research, this may allow them to release the drug commercially alongside the pivotal phase in 2022.
If so, compassionate use isn't even needed.
I don't see any of this as the FDA slowing Frequency Therapeutics down at all. I see it as Frequency Therapeutics and the FDA leveraging a partnership to get the drug out faster than average, while identifying risks, efficacy and effectiveness appropriately.