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The responder definitions are not the same, Frequency Therapeutics uses the Thornton Raffin scale to classify a responder which is a pretty high...
One issue with the X+Y argument is that there might be a ceiling effect to X that dwarfs Y and you don't quite have the candidate profile to...
I agree it's bizarre they did no validation of baseline data.They reported only the responder rate. I wish they had put out some more metrics on...
If it does lead to hair cell loss, shouldn't FX-322 be able to do its magic? Do we summarize that no vascular build up is a necessary condition...
What does the failure of age-related hearing loss mean in terms of how FX-322 may be working? Can we make any new hypotheses on the mechanism of...
My understanding of this is there will be a couple of tests before a baseline is accepted. I think they will want to see stable word recognition...
Good one :) At the end of the day we let the data take us where we want to go or where we have to go :)
I meant in a Phase 2 trial we are looking for a signal and trying to find the right dose. I do not think a Phase 2 is powered to observe...
Based on my understanding Frequency Therapeutics is saying all arms, all doses behaved the same. All treatment arms were impacted by the lawn...
Ultimately the proof that the drug works and is safe is confirmed in a pivotal trial.We need to know the dose to do that. It's not clear to me...
On the following hypothetical: If Phase 1 showed safety and no effect but Phase 2 did show efficacy, Phase 2 would have shown a multiple dose...
If we ignore the phase monikers, essentially the reported Phase 2 trials and Phase 1 trials differ in n and probably the randomization criteria....
I think it really comes down to the upcoming readouts. If the readouts are similar to the Phase 1, it is quite possible in my opinion. Whether...
Based on my understanding, Phase 1 is very low n to show drug does not have major safety issues. Phase 2 trials are meant to enlarge population...
Essentially what has been stated by Frequency Therapeutics is an artificially low baseline was established. The faker intent being speculated here...
