I'm certainly no basher and am heavily (over) inve
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Posted On: 01/05/2018 4:12:57 PM
I'm certainly no basher and am heavily (over) invested. I want this thing to soar. And I like the potential of Eltoprazine.
But let's not exaggerate the orphan designations. You say chances were not likely they would get it and its not easy to them.
I don't believe that is the case. Here is a good (and relevant) article on the subject from Adam Feuerstein.
"Too many investors have a fundamental misunderstanding about the significance of orphan drug designation. I should say, insignificance, because the FDA delineation, on its own, means very little. Yet almost every day, biotech companies like Anavex issue press releases touting orphan drug designation as if it were an achievement of supreme importance.
It's not, and I'll explain why below.
Anavex issued said press release on Friday. It contains a wee bit of truth. On April 6, the U.S. Food and Drug Administration granted orphan drug designation to the company's experimental compound Anavex 3-71 for the treatment of frontotemporal dementia.
But then, Anavex goes off the rails with this canned quote from Kristina Capiak, vice president of regulatory affairs: "We believe that Orphan Drug Designation for Anavex 3-71 for the treatment of frontotemporal dementia is a significant achievement."
Sure, if you consider answering eight questions on a standardized Food and Drug Administration form to be a "significant achievement."
Answer eight questions on an FDA form. Do it correctly. Make two copies of the form. Send to FDA. That's all it takes for any biotech and drug company to secure orphan drug designation from the FDA. It's really that easy.
Is that a "significant achievement"? No, except if your ulterior motive is to hoodwink gullible retail investors into buying your stock."
Hoping for news next Monday, Tuesday or Wednesday!
But let's not exaggerate the orphan designations. You say chances were not likely they would get it and its not easy to them.
I don't believe that is the case. Here is a good (and relevant) article on the subject from Adam Feuerstein.
"Too many investors have a fundamental misunderstanding about the significance of orphan drug designation. I should say, insignificance, because the FDA delineation, on its own, means very little. Yet almost every day, biotech companies like Anavex issue press releases touting orphan drug designation as if it were an achievement of supreme importance.
It's not, and I'll explain why below.
Anavex issued said press release on Friday. It contains a wee bit of truth. On April 6, the U.S. Food and Drug Administration granted orphan drug designation to the company's experimental compound Anavex 3-71 for the treatment of frontotemporal dementia.
But then, Anavex goes off the rails with this canned quote from Kristina Capiak, vice president of regulatory affairs: "We believe that Orphan Drug Designation for Anavex 3-71 for the treatment of frontotemporal dementia is a significant achievement."
Sure, if you consider answering eight questions on a standardized Food and Drug Administration form to be a "significant achievement."
Answer eight questions on an FDA form. Do it correctly. Make two copies of the form. Send to FDA. That's all it takes for any biotech and drug company to secure orphan drug designation from the FDA. It's really that easy.
Is that a "significant achievement"? No, except if your ulterior motive is to hoodwink gullible retail investors into buying your stock."
Hoping for news next Monday, Tuesday or Wednesday!
Quote:
Getting back to the worthless Elto. If that was the case, then Dr. Lowe really tricked the company bring it to them. If that were the case, the company really tricked the FDA when they said they WOULD apply for orphan designation for Elto and they DID receive it.
But people hear what they want to here and would have taken that as the company WILL get orphan designation. Chances were not likely, but they did.
Amarantus Receives Orphan Drug Designation From the US FDA for Eltoprazine in the Treatment of Parkinson's Disease Levodopa-Induced Dyskinesia
Feb 10, 2016
https://www.prnewswire.com/news-releases/amar...96831.html
The fact of the matter is it's not easy to get orphan designations and the company as multiple. It's not easy to get patents, but the company has a boat load. Has that sent the stock to $100, obviously not, but at least in the last year, they haven't been sitting on their thumbs wondering what to do.
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