I still believe they have to go through FDA process, see below what Nasrat said in CC. I leave this to no2koolaid and winechemist to further comment.
"
Isradipine, results of Phase 3 trial of over 300 subjects on use of Isradipine to treat
Parkinson's disease is supposed to be released early this calendar year? I believe it’s
March, around the March timeframe.
What impact on sales of Isradipine do you see if the drug is approved for Parkinson's? Of
course, the FDA approval process would have to be followed. But, as I recall, Elite is one
of only two to three who make Isradipine. Is that correct? Yes, that is correct. We are one
of few companies that make Isradipine. We also have patients who have Parkinson’s
calling Elite directly and asking for Isradipine. And we cannot do that. First, because we
are not a pharmaceutical company -- we are not a pharmacy; we are a pharmaceutical
company. We are not allowed to sell directly to the patients. And second, because this will
be off label use.
The impact, I don’t know what the impact is going to be because there are so many other
factors that run into this. First, the results that our coming in March have to be favorable.
They got to be clearly favorable that show that actually Isradipine makes an impact on
Parkinson's patients. I don’t know what the answer is going to be or whether it is or it’s not.
Okay?
Second, the FDA needs to make decision if they need other trials from the sponsor or they
are going to accept this and have them put the application together. And then, you have to
file an application and then gets approval and then make the announcement that yes,
Isradipine works on Parkinson’s. So, I'm watching this very closely but it’s going to be a
while before we get to where everybody would like to see. And I do believe, I hope that’s
going to be a very positive thing for Elite.
"
