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Re: Jimmy Joe post# 312398

Saturday, 03/23/2019 11:25:24 AM

Saturday, March 23, 2019 11:25:24 AM

Post# of 403114

The FDA should have nothing whatsoever to do with anything. As you yourself have stated word has pretty much been mum with regard to this drug and its potential use for PD. Study results will be out in early May.

...

Highly doubt anything has been said about anything with regard to study results. And having said that results are pretty much under lock and key until early May how would anyone be privy to results?







I'm not sure which post this is responding to. My post was about tempered expectations for isradipine news and hopeful expectations about isradipine sales. I also pointed out that Elite would get both positive and negative attention if they try to issue a PR associating their generic isradipine with STEADYPD-III results, once they are available to the public, and if they are positive. As we all know, even great results will not automatically add PD to the indications on the official FDA label. If any company goes out and publicly touts their drug for an indication that is not on the label, then you better believe the FDA will have something to say about it. I never suggested anything about insider information or knowing the results before May. I cannot fathom how this response follows my post.



https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147745017

What do you know about the company's intentions for a PR in the event the results are good? Easily justifiable as a material event to try to associate ELTP's isradipine with STEADYPD-III, but very, very sticky territory with the FDA. They tend to frown upon drug companies advocating for an off-label use of any drug.








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