BrainStorm Cell Therapeutics Inc (BCLI)

[sokol]

It should. To add a new indication for an approved drug a supplemental drug application is filed with the FDA. Relevant information, data and findings from the clinical trails Brainstorm has conducted may be used to support the supplemental application.

Also, once a drug has been approved for one indication, it may be prescribed off label; however, I am not so sure that physicians will be willing to prescribe NurOwn infusions off label for these other diseases you mention. I think it is highly doubtful that NurOwn will be prescribed off label. That said, there is such a thing as compassionate use special access scheme that may come into play. For example, Australia has such a scheme that allows Australians access to drugs - especially drugs that have received some sort of approval elsewhere. I am not sure how compassionate use under a special access scheme would work for an infusion drug like NurOwn. Physicians have to submit a request for such a use, and the submitting physician is not relieved of any liability for prescribing a drug under the compassionate use special access scheme even if the scheme is approved by regulatory authorities.