* The investigator sponsored PII trial had no placebo comparator - i.e. it was just a baseline comparison. Therefore, the recorded discomfort response could just be a 'placebo effect'.
* I appreciate a different dye was used - but I'm conceding that it has a fighting chance in the signs end-point. All my concerns are focussed on the symptoms end-point.
* A point I didn't make in my original E-Mail is a dry eye indication trial success is almost an oxymoron. Restasis has barely any efficacy. I had intended to short ISTA but the result came earlier than I expected. I think Regenerx management have had dollar signs in their eyes (dollar eye disease?) chasing after dry eye while an orphan indication like eye ulcers would be much better - I do believe failure here will say more about management than thymosin-beta 4.
Thank you SO MUCH for some very insightful input. REALLY! It's not good to have a one way street. And you don't bash, but you "logic". I am sure we all will listen and read.
Go bacjk and review the compasionate use IND of TB 4. Even where some pts did not get the response, RGRX stated that 100% got ease of occular discomfort. Human data, not mice. The FDA themselves gave the compassionte use IND. Think of it this way? If TB 4 shgowed a response rate in eye ulcers where nothong worked previous, and got a 70% response rate...and in 50% of pts got a total cure rate......and the FDA knows RESTASIS is not that good...do you really think the FDA will nirt recognize that? I think it a mitigating circumstance over the placebo possible comforting saline drops. because saline drops DO NOT show efficacy or cure rates! TB 4 did in humans!
second? I suggest you research Ora Inc. they take intp account the stuff you worry (i think). They create a room or chambetr they refer to as CAE. Controlled Adverse Envirnment. They FDA loves what ORA does. By dosing pts in an adverse envirn, it makes it a harsher envirn.which makes plavebo less likey to show...and will highlight any possible efficacy by drug.
Dry EYE a huge problem. ReSTASIS is not good. There is no other therapy. It is a $2.8 billion world category. I cannot believe the FDA will reject TB 4 is it shopw s FAR BETTER efficacy on HEALING eye ulcer issues simpley becaise a saline solutoon lesssened discomfort????? The saline solution DID NOT SHOW EFFICACY OR CURE!
Please, keep posting! It is very refreshing and thought provoking!! Really.