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HoustonTX
Posted on: Sep 20 2017, 12:16 AM


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Posts: 3

I read the release a number of times, and I agree it is ambiguous. It is not clear if they indicate that they'll have the last module of the NDA application submitted by December 2017, or just the safety data. Or, perhaps the safety data is the last module?

In any case, it sounds positive that a REMS protocol will not be required and that Clinuvel can instead mirror what it has already been doing in Europe with respect to PASS.

Looking forward to December and confirmation on timing.
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HoustonTX
Posted on: Jun 28 2017, 12:15 AM


Group: Member
Posts: 3

I like your optimism, but I just read a June 2017 interview with Lachlan Hay where he indicated that the FDA NDA would not be filed in the first half of 2017, but hopefully by the end of the year. That being the case, I imagine an FDA decision will not be forthcoming any time soon.
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HoustonTX
Posted on: Feb 11 2016, 08:05 AM


Group: Member
Posts: 3

My German is pretty rusty, so I ran the article through Google's translator. So, FWIW, the article appears to discuss Florian Hamm's earlier legal troubles, his new outlook on life and his thoughts on current investments. He goes on to say there are a multitude of businesses that are candidates to short, but he characterizes Clinuvel as a long-term investment.
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