It basically says they lost: "The U.S. District Court for the District of Maryland dismissed StemCells’ patent-infringement case against Neuralstem with prejudice, in favor of Neuralstem.
The case concerned certain patents surrounding StemCells’ (ticker: STEM) neuronal stem cells. However, dismissal of the case was due to a third-party scientist who is a..."
Also google DSM-V for mental illness and retardation. That will explain the rest.
Promising drug candidates are not a dime a dozen. They're very rare. If something else comes down the pike you can bet your dollar that every other large pharma company on the planet will also be bidding on it. It's not that simple a situation for this company.
You're assuming 100% market penetration, that all 12,000 SCI patients will be able to get this. That seems overambitious. Some patients' internal injuries will preclude the procedure. Some patients will come in with no insurance. And some doctors will naturally recommend a different treatment course for whatever reason. 100% market penetration is too ambitious. Otherwise, looks like a decent market projection if the treatment reaches the market (which so far looks good to happen).
If there is an NDA, the company decided it was in its best interests at the time of the original post to release that information. NDA doesn't mean no information ever.
Open label doesn't mean no NDAs are signed misi. It just means the docs and the company can see the results as they come in - but NDAs are still SOP since the results are a company secret until they are announced in public.
SOP for clinical trials is patient signs NDA before participating in the trial.
There have been numerous violations of agreements by patients in trials in the past, but most companies have better things to do than sue their own clinical trial participants, so we may hear from him yet.