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Re: turks post# 12171

Sunday, 08/13/2017 2:55:54 PM

Sunday, August 13, 2017 2:55:54 PM

Post# of 16885
If you look at how Braeburn has used 505(b)(2) as an example, they would do a limited Phase 1/2 for dosing/safety (maybe 20 patients), and then follow up with two Phase 3's (50 participants for each), one for efficacy and one for safety. Zacks's timeline is approval in late 2019, which would mean NDA submission late 2018 or early 2019.

On the type 2 diabetes, I just thought it interesting they called it out again and said they would only focus development on drugs where they could have a partner/funding from the outset. Victoza is a 3 billion drug that just went off patent, so I would assume Novo Nordisk would be interested in a way to extend patent life...maybe through Pro Neura.

Also nice to hear that the government is fully funding the malaria study. So if it goes to the FDA, the government pays the bill. Nice deal if it works.

IND submission won't do much for the price right now in my opinion. We are stuck down here for awhile.

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