Then I don't get it. If Phase 3 will also have a placebo, what's the point of a Phase 3? Just more people? So it wouldn't be beneficial to try to get into the next trial. I guess we hope they just release it after this phase.
The trouble is that even in phase 3 trials, companies like Frequency Therapeutics still need to demonstrate that the medicine works, the medicine delivers the intended outcomes and that there is no placebo effect.
While it might seem largely pointless to be basically repeating the phase 2 trial with larger numbers of participants, it is necessary to demonstrate that the medicine works with a very big cohort in order to validate its effectiveness.
It doesn't matter that ear medicines and specifically hearing medicines can demonstrate their effectiveness with a small cohort. This is because all medicines are required to follow the same FDA rules to obtain approval to get it released.
Therefore it is quite possible that the following things will happen regarding trial progression and the release of FX-322:
1. If the current trials demonstrate that FX-322 is effective, Frequency Therapeutics will probably be able to apply for compassionate use allowance from the FDA. It is probable that the FDA could grant compassionate use to Frequency Therapeutics because it would appear FX-322 would satisfy the relevant criteria.
2. If Frequency Therapeutics obtains compassionate use then FX-322 could be released after the current trial. This is very possible since Frequency Therapeutics said they would consider applying to obtain compassionate use from the FDA and then granting this to potential FX-322 users.
Frequency Therapeutics would however still be required to take FX-322 through the phase 3 trial process to satisfy FDA requirements completely.
3. Frequency Therapeutics would commence the overseas trials in Asia and Europe. These trials would be recognised by the FDA as being compliant with the phase 3 trial requirements. Frequency Therapeutics would also satisfy the agreement they have with Astellas to conduct and complete trials in Asia and Europe. Provided the FDA declares these phase 3 trial as satisfactory, Frequency Therapeutics would then be able to release the medicine globally and also freely.
While it does seem stupid and it does suck that Frequency Therapeutics need to take FX-322 through a phase 3 trial, this is completely necessary to satisfy the FDA requirements. Furthermore it will prevent those against FX-322 or any other hearing medicine being able to make claims which question its safety or challenge its effectiveness for nefarious purposes.
Thus while the FDA process is protracted, it is ultimately going to ensure that the medicine is effective, safe and most importantly enables it to be used.
At this point in time, I think that Frequency Therapeutics has set things up well and laid the groundwork to possibly get its medicine FX-322 released early in some jurisdictions under the compassionate use rules.