Aldeyra Therapeutics Inc (ALDX)

[Carjockey2]

Dumped at 11.20 when I saw it didn't hold I'll be watching for re-entry great gains this week very nice play!!!!!

[MonstaGains]

I dumped at 11.30 i think shes overbought here and correction is coming

[Carjockey2]

Wow...I love this stock.....

11.55

[Investor2014]

So Seventh it was all dandy then, let's hope the other stock beginning with 'A' that we follow eventually goes the same way.

[TheFinalCD]

$11.15

INCREDIBLE

ALDX

CONGRAT$

[TheFinalCD]

$10'S LOOK LIKELY TODAY

[Tdash]

traded like a beast today.. nice

[mta65]

This stock is screaming two days in a row. Thoughts?

[Investor2014]

Have seen the unexpected strong placebo effect too. In a U.K. cat allergy trial the reduction in allergic reaction was 60% and exactly 60% too for the placebo arm in phase 3 study. In the phase 2 studies the drug had proven superior statistical significance.

I do agree that the ALDX choice of 0.1% solution is worrisome, particularly as I have seen no dose response data or explanation of this assumed minimum response dose.

As you said, nor is it clear what ALDX have agreed with the FDA. Is it confirmation of statistical significance against placebo for the 0.5% dose, while simply accepting whatever minimal dose effect we get. Or is there some set expectation from the 0.1% arm.

I don't know, but CEO Brady seems to think it is all Dandy. I guess only time will tell.

[seventhwave]

"vehicle/placebo showed a greater than expected effect" is a phrase everyone fears in clinical testing and can often be a dealkiller. Trials designed to test against an inert placebo may seem like easy slam dunks (vs. active SOC) until the trial design is violated in practice and the fail is uncovered only after unblinding at the fag end. Happened to ITEK when some patients in just 2 trial sites figured they got the placebo and helped themselves to alt. treatment undisclosed while on the trial. If something similar happened with the ALDX p2a trial, thankfully their 0.5% dose was strong enough to hit the ball out of the park in every instance to render the trial a success regardless of placebo 'outperformance.' If there is similar placebo activity in p2b, I'm pretty sure the 0.1% arm will not beat it. I'm not sure how the market will read this outcome and not optimistic of a favorable interpretation. I wish the comparator arm was the current SOC to avoid trial abuse.
I've quadrupled down here and will take half off the table before readout. Not expecting a rapid/robust bounce-back as ALDX has relatively few deep-pocketed/fluid sponsors but it will climb over May & June into announcement. In this unreal market, investors are the tail wagging the market dog and the trail the price traces is more their imprint than an efficient reflection of co. fundamentals.

[Investor2014]

Seems little ALDX is now exposed to the 'good news push the sp down' manipulation...

[Investor2014]

Having looked again at Clinicaltrials.gov and thought about it, [ceiling] possible should have been 'healing'.

It seems vehicle, that is the placebo, had greater than expected effect, while 0.5% dose still showed superior statistical significance. I don't know how Aldeyra have arrived at 0.1% as the control arm for establishing minimum effective dose (as required by the FDA), but we must assume they have previously determined some form of dose response curve to make them confident that 0.1% is high enough to show effect against even a strong placebo effect.

Then Tom Brady is adding that, all that being correct, establishing minimum effective dose is all they are missing to potentially have the FDA agree the P2b trial and results leading directly to a P3 registration trial.

Understand your concern on how Aldeyra chose 0.1% and why they feel confident about that being a minimum effective dose. Hopefully IR will eventually provide a reply to you (let us know), but I guess we just have to decide if we trust Tom Brady and crew on the science.

I might double or quadruple down. If successful the rest of the pipeline, not least ADX-102 in SLS with Orphan Drug Designation, is awesome.

[Investor2014]

I think [ceiling] is a best guess filled in word by the conference call service due to the audio being intelligible to them.

Your interpretation is probably right.

I considering adding too. The ALDX pipeline, and possibly beyond, is attractive assuming the whole aldehyde trapping approach ultimately turns out to be right.

[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.

[Investor2014]

7thwave,

I have held a small'ish position in ALDX for about a year and keep an eye.

My (educated layman's) view on the science is positive. With regards to your question, I think the quote below from the latest investor's call sounds objectively confident.

The 0.1% arm is meant as a control against the statistically SUPERIOR 0.5% dose. Since the response was higher than anticipated with 0.5%, and presumably with a dose response curve being available, I think it is reasonable to expect to see a statistically significant response also at 0.1%.

As always only time will tell...

Todd Brady

Yes. Good morning, Adam. And thank you for the question. It's a very interesting question because there are some changes to the Phase 2b but I think they are very positive changes and they are based on discussions with the FDA. I'd say successful discussions with the FDA. The first thing I'll note is the Phase 2b for Allergic Conjunctivitis is two doses of drug. This is a standard requirement from the agency that you establish what is generally known as the minimally effective dose. So we've selected the dose we used in the last trial which was statistically superior to vehicle. And in addition a lower dose, it's 0.5% what we used prior, 0.1% is what we are using in this trial. As we said last year we did see a higher than anticipated vehicle response in the Phase 2a study that we described in February of last year. 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. We consider this a major success we think in theory increases the odds of success in the Phase 2b. The one thing I will note, Adam, and I know you know this but if the trial, the Phase 2b trial is positive then it could emphasis on could be considered one of two pivotal trials for approval and the indication. So one possible scenario I'd say an upside scenario is an addition to the Phase 2b if positive, you would perform a Phase III subsequently and then be in a potential position to file an NDA. So I think that answers your question. There are some differences but I think they are in our favor.

[seventhwave]

Investor2014, not sure if you follow ALDX closely but with the ongoing allergic conjunctivitis p2b trial do you know why the FDA told mgmt to add the 0.1% arm? makes me very nervous dreading the scenario 0.5% statistically succeeds as before while 0.1% fails. If mgmt isn;t interested in testing/selling 0.1% why is FDA forcing it to?

[seventhwave]

Pretty cut & dry clinical testing schedule with allergic conjunctivitis p2b results next on tap shortly.

Seems to me the dip is due to one of the current insty's lightening up. Small float with thin trading causes insty moves to stand out like a sore thumb for the mkt. makers.

Thinking, it will regain high 4's once it clears but fail to break 5 until runup top2b results.

GLTA

[Investor2014]

Orphan drug designation announced and the SP tanks. Is that small biotech manipulation or what?

[IPO$]

Terrible IR firm here

[IPO$]

Up nicely since your post 2 weeks ago. Charts show it going higher as I interpret it.

[BEANPOLE]

It looks like a nice day here at Aldeyra. Gapping up nicely. $(ALDX)$

[IPO$]

was it National or Aegis who did it?

[IPO$]

offering proved to be fruitful to investors with PPS now at $9. I met the Dr. and his team...very good bunch of folks...

[RealGenius]

Secondary offering at $7.50

[IPO$]

profit taking today

[IPO$]

Co out of Mass. w/ ties to RTP in NC.

[IPO$]

RUTH IR out of NYC on this one.

[IPO$]

The Company is developing a treatment for diseases thought to be related to high levels of free aldehydes, naturally occurring pro-inflammatory toxins.

[IPO$]

I love this company.