Is this actually a possibility?
Yes release after Phase 2a is possible for a number of reasons:
1. Frequency Therapeutics has been granted Fast Track status and compassionate use allowance by the FDA because FX-322 is a new medicine to treat an unmet need. This enables Frequency Therapeutics to release the medicine if it successfully completes and passes phase 2 trials under the 'Right to Try' and 'Compassionate Access' provisions if they choose to so.
2. Commentary from Frequency Therapeutics staff has indicated that they would be open to considering allowing early access to FX-322 if they believed it delivered outcomes which warranted early release/access.
3. There is clear desire and interest from consumers in getting FX-322 at the earliest possible time. This means Frequency Therapeutics stands to benefit earlier with sales than they would if the medicine was not actually released until after completing the full trial process first. Furthermore customers could get FX-322 much sooner as well.
4. Fortunately ear medicine and specifically ear medicine which treats hearing, has a very low chance of delivering false results which don't indicate the true outcomes and/or true effectiveness of the medicine.
This means that if trial participants gain improvement(s) with FX-322, it is highly likely that these are genuine and also real outcomes which would be validated by the FDA. This means the FDA can be very confident that FX-322 is working as it is expected to.
The previous trial demonstrated that various stakeholders could be confident in the trial result when only those who were given FX-322 demonstrated hearing improvement.
5. it is quite obvious that Frequency Therapeutics has focused solely on completing the trials in the US first for two reasons:
Firstly, because trials in the US are relevant and required to get FX-322 approved in the US by the FDA.
Secondly, completing the final or pivotal trial(s) overseas has no bearing on whether Frequency Therapeutics can obtain approval from the FDA to release FX-322 through compassionate use allowances. Companies are only required to complete one trial in the US and Frequency Therapeutics are doing this by completing the phase 2a trial there.
Therefore the FDA will recognise future trials including the final or pivotal trial conducted overseas by pharma companies based in the US.
So by completing trials in the US first, Frequency Therapeutics will have done what is required to release the medicine in the US under both the compassionate use provision and to get the final FDA approval.
This means Frequency Therapeutics can start selling the treatments in the US as soon as possible, obtain their payment from Astellas for running the trials in Asia and Europe and still successfully comply with the overall requirements to fulfil the FDA process.
Therefore I think that it is truly possible that Frequency Therapeutics might release FX-322 after phase 2a providing it actually satisfies the FDA requirements.
While Frequency Therapeutics will get in trouble if they directly comment that they are going to release FX-322 through compassionate access, we know they have indicated many times and through many platforms that they have a clear desire to help people as quickly as possible. Furthermore I feel that Frequency Therapeutics have certainly laid the framework to potentially be able to release FX-322 early after the current trial is done.
So I would say that an early release post phase 2a does currently seem to be very possible.