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Re: Zenguy post# 2299

Tuesday, 11/06/2018 3:57:02 PM

Tuesday, November 06, 2018 3:57:02 PM

Post# of 3857
Hi Zenguy,

I like hearing updates from the companies I invest in. I Tweeted this morning where I highlighted some key sentences:



I love the mention of the results being under review by a scientific medical journal.

I love the fact that Dr. Schoser is our advisor because you can Google his history/accomplishments.

I love hearing they'll "likely" proceed with clinical studies in accordance with FDA and EMA protocols. After all, this is what I mentioned reading about in the Annual Report (10-K)... Open up that document and search for "FDA" to see they've had correspondence mentioned on Page 6. Stuff that happened back in September 2017, in fact.

Then, Page 7 of the 10-K says:

"The FDA pathway for the development of drugs for certain of these genetic muscular diseases may fall under the Orphan Drug Act of 1983 , which was passed by the U.S. Congress to facilitate the development of orphan drugs. The FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition that affects fewer than 200,000 individuals annually in the United States. Such an orphan drug designation may entitle a recipient to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax credits for certain research and user fee waivers under certain circumstances."

I love it. I hope we hear about that soon.

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