Thursday, March 24, 2016 6:36:24 PM
Each patient will have one lesion of severity 3 that will be measured throughout treatment. The goal is to have that lesion drop to 1 or less by the end of treatment. The primary efficacy endpoint is the % of people who have that response. Someone else might be able to say what a good percentage would be. Since Prurisol is easily administered and has minimal to no side effects, I suspect the percentage does not need to be that high for a success. I don't know how this springboards them to severe cases but perhaps if the "3's" clear up really well that might be reason to believe that 4's/5's should be tested in a phase 3 trial.
Note that the trial dosing ended on 3/1 according to trial parameters, follow ups would continue for 28 days. We received a PR stating that the last patient finished their follow up on 3/17. It's hard to imagine they could reduce they follow up time so much if there was anything other than complete success or total failure in that last patient.
As for the article...
Leo appears very confident, almost cocky. This removes all doubt in my mind that he has a feel for the results at this time.
Do you really think he's going to pay to put out a piece in which he says "yeah we took the riskiest and most difficult route with this trial" before knowing if it was the right thing to do? Of course not. This results in two reactions:
1) Increased uncertainty about the trial results due to a more difficult path. This hurts the stock price very short-term and will affect the price at which we can sell to Aspire prior Prurisol results if they choose to do that for any reason.
2) If Prurisol failed, that would indicate a huge lack of judgment on the part of the executive team at a time when they would then need to appeal to the investing public for funding going forward (either directly though the Shelf or indirectly though stock price with Aspire).
There is much to be lost there and nothing to gain aside from Leo looking very good on success. In addition, this was published after they found out there were no unexpected trial-derailing SAEs. Others have said here that the mouse models are extremely good at predicting efficacy but poor at predicting safety. This has resulted in a change in tone from uncertainty to confidence when compared to the 3/1 PR. One must also consider the stock price spike on Friday over "nothing" also needs to be taken into account.
If there were ever dots to connect they're sitting right there in front of you.
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