Wednesday, August 17, 2016 4:31:39 AM
ITEK:
At the R&D day in December last year they talked a bit about the Phase 2 and have several slides. I don't know if its still on their website but I made a PDF of the slides if you PM me here or SI (same alias) I can email them to you. Here are a couple of the summary slides
The company said FDA has refused to approval Timolol/Latanoprost combo I don't know if that is formally or just because of the safety (drop in heart rate) concern.
The current registration study (first Phase 3 read out later this year) is monotherapy anyway though Timol is an active control. They are also testing a higher dose than in Phase 2. If the company is telling the truth that FDA will accept improvement over placebo (which they say they have in writing) the bar is pretty low. And as far as combo goes if FDA won't approve a prostaglandin and Timolol option this should be a nice additional agent available to glaucoma patients.
I am long too with the ubiquitous small position
At the R&D day in December last year they talked a bit about the Phase 2 and have several slides. I don't know if its still on their website but I made a PDF of the slides if you PM me here or SI (same alias) I can email them to you. Here are a couple of the summary slides
The company said FDA has refused to approval Timolol/Latanoprost combo I don't know if that is formally or just because of the safety (drop in heart rate) concern.
The current registration study (first Phase 3 read out later this year) is monotherapy anyway though Timol is an active control. They are also testing a higher dose than in Phase 2. If the company is telling the truth that FDA will accept improvement over placebo (which they say they have in writing) the bar is pretty low. And as far as combo goes if FDA won't approve a prostaglandin and Timolol option this should be a nice additional agent available to glaucoma patients.
I am long too with the ubiquitous small position
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