Aldeyra Therapeutics Inc (ALDX)

[seventhwave]

Investor2014, Thx for your response. Still can't get my arms around what constitutes a successful outcome in this 3-arm trial. I have no doubt the 0.5% arm will succeed to demonstrate statistical significance as before. I have doubts the 0.1% arm will do the same in a statistically meaningful way. I would think the headline would then deem the p2b trial a failure.

The 3 arms are:
Drug: ADX-102 Ophthalmic Drops (0.5%)
Drug: ADX-102 Ophthalmic Drops (0.1%)
Drug: Vehicle of ADX-102 Ophthalmic Drops

Mgmt. says...

This is a standard requirement from the agency that you establish what is generally known as the minimally effective dose...
...The discussions with the agency centered around what is an appropriate control and we've convinced the agency to allow us to use [ceiling] as the control such that there is no doubt that there is any interaction between the vehicle and the allergens used to stimulate the response in the eyes of the subjects.

I don't understand the last line, including:
"use [ceiling] as control" - is that the 0.5% dose as control?
"...such that there is no doubt that there is any interaction between the vehicle and the allergens used to stimulate the response" - totally missing how this would be proved by inclusion on 0.1%. Outcome of 0.1% should have no bearing on proof that the inactive vehicle has no effect on the allergic conjunctivitis condition. ie. it is immaterial if 0.1% arm statistically succeeds or fails as long as the inert vehicle arm does not outperform it.

I have written IR & Tulipano a note but doubt I'll receive a response.

FYI, I too had a small position but upped it to meaningful size on this downswing on expectation of readout in June/early-July.