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Re: LuCo post# 27236

Tuesday, 10/21/2014 9:00:03 AM

Tuesday, October 21, 2014 9:00:03 AM

Post# of 144813
THIS IS HOW LONG YOU SHOULD EXPECT TO WAIT FOR CELL IN A BOX TO ENTER THE MARKET.

Preclinical studies can be relatively quick to discern a potential “clinical benefit” or to recognize an endpoint such as any amount of shrinkage in a tumor that can lead to the relief of associated pain, and the duration of time for the onset of ascites with and without the use of Nuvilex’s Cell-in-a-Box/ifosfamide combination.  If TD2 is successful, the company could then enter Phase 1 clinical trials in humans and again, these trials could be relatively short, and if they too are successful, Nuvilex could receive accelerated approval using Phase 1 data.  Yes, companies have been granted accelerated approval based solely on Phase 1 data as the designation is designed for drugs or biological products in early phase trials.
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