BrainStorm Cell Therapeutics Inc (BCLI)

[Fmello]

I read this on the No More Excuses! ALS Watchdog Group on Facebook:

Wanted to clarify an issue for everyone about Brainstorm unblinding its Phase III data.

1. Only the people in the trial & their doctors will know who got NurOwn and who got placebo. Federal HIPAA Privacy laws prohibit Brainstorm & the trial sites from releasing that information to ANYONE. No one in the community will know what people got unless each person decides to disclose it.

2. Drug sponsors have data in trials de-identified so right Brainstorm doesn't even know who is who as it is analyzing the data.

3. Until the BLA is submitted & the FDA confirms for Brainstorm that they have all the data they need to make a decision, it would be a mistake to unblind the data now. What if the FDA sees something and wants more analysis done on a signal in the trial? If the data is unblinded, Brainstorm couldnt respond to the FDA's request. Unblinding would only hurt Brainstorm's ability to respond to any requests from the FDA, which would hurt the eventual chance of drug approval.

4. Brainstorm's biomarker data that Bob Brown presented in abstract form at the ALS-MND was INCREDIBLY PROMISING. It will help support approval. But -- it is also the very first trial EVER in ALS that has this many biomarkers. These biomarkers aren't "validated" (like A1C is for diabetes). That means Brainstorm had to do the initial investigative work to see if they are correlated to the other data in the trial. In essence, they are the first to "discover this science." Unfortunately, that means it takes times that no one has to wait.

Nothing, absolutely nothing, moves with urgency in ALS.

It sucks. It's not fair. It's tragic. There aren't enough words to express how horrific this is.
But I trust the PIs in this trial implictly. I trust the Bob Brown, Merit Cudkowiz, Tony Windebank, Nathan Staff, Namita Goyal etc to push Brainstorm as hard as they can to file, while recognizing what they likely need for the FDA. Collectively, they've been PIs in hundreds of trials & they know what level of evidence it might take to convince the FDA. They know better than us. We don't want Brainstorm to file before they have everything in order to give you guys the best chance. The PIs know what that is.

So keep the faith. If Brainstorm & the PIs believed it was hopeless, they would have said so & would have just abandoned NurOwn. They wouldn't keep doing presentations at scientific conferences.

Once the BLA is filed, we will launch into advocacy. But we need to let the experts do their jobs then we can do ours to fight for approval.