The ALS clock is running.
In the next few weeks, the FDA will make a decision regarding approval of NurOwn for ALS.
Either way, another trial will be needed, so let's get moving.
If NurOwn is approved
Another trial will still be needed to confirm efficacy.
It is unlikely that payers will step up to pay for the therapy, so the confirmatory trial will be one path to affordable access (albeit with potential placebo exposure) for those who cannot self-pay. For those who can self-pay or raise funds or get insurance coverage, they will be able to purchase commercial access to the therapy.
If NurOwn is not approved
Another trial will be needed to produce efficacy data.
The trial will provide access (albeit with potential placebo exposure again) to those who can get in, and an Expanded Access Program (EAP) can provide broad access for those who cannot get into the trial.
"We can't afford it" need not be a Brainstorm excuse.
There are public funds available to help them via Act for ALS.
And Brainstorm can use the cost-recovery option allowed for EAP in order to remain whole while offering Expanded Access. People with ALS would still have to pay, but it would be cost only, without any profits that they would be responsible for with an approved product.
All roads lead to another clinical trial. Let's get going.
We can't afford another three years of rearranging existing data. We have seen anecdotal evidence of efficacy that makes it unconscionable to horse around any longer.
Let's get on with it and run the trial and provide access to people with ALS who want access. Now.
