Title: This Week in Pharma: Is Anavex’s Hype Based on Data or Anecdotes? Can Mast’s Vapoloxamer be successful a second time around?
Summary:
This column presents questions on Anavex’s 2-73 and Mast’s Vepoloxamer. Based on your votes for the more interesting topic, Slingshot Insights will sponsor the expert’s cost.
Join the project of the winning topic to submit your own questions, access dial-in details, and review the transcript.
Option 1: Analyzing Anavex’s 2-73 after news of positive response in Alzheimer’s patients sends stock upwards. Is the optimism based on data or anecdotes?
Option 2: Investigating the market potential and chances of approval for Mast Therapeutics’ Vepoloxamer in treatment of vaso-occlusive crisis from sickle cell …show more content…
What does it suggest about the safety and efficacy of the drug?
The primary endpoint of their recently announced Phase IIa extension trial is "to establish continued safety and tolerability of ANAVEX 2-73," which is very vague. Can you discuss the use of this endpoint, and give us a better idea of how this will be measured?
Secondary endpoints include "exploratory cognitive as well as functional measures using Mini Mental State Examination (MMSE) and evaluation of Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL), respectively." Can you discuss these measures? Are they appropriate and clinically relevant?
What are important things to look for in the Phase IIa extension study?
There have been recent news stories that say patients on 2-73 have regained the ability to paint, play the piano, and showed other signs of reversal of memory loss. Can you discuss these findings and their clinical relevance? Is there anything in the data that supports these findings, or are these mostly anecdotal benefits?
What results from Phase IIa would we have to see for 2-73 to be successful in regulatory efforts? How do you view Anavex's chances of receiving approval for the product?
In
Summary:
This column presents questions on Anavex’s 2-73 and Mast’s Vepoloxamer. Based on your votes for the more interesting topic, Slingshot Insights will sponsor the expert’s cost.
Join the project of the winning topic to submit your own questions, access dial-in details, and review the transcript.
Option 1: Analyzing Anavex’s 2-73 after news of positive response in Alzheimer’s patients sends stock upwards. Is the optimism based on data or anecdotes?
Option 2: Investigating the market potential and chances of approval for Mast Therapeutics’ Vepoloxamer in treatment of vaso-occlusive crisis from sickle cell …show more content…
What does it suggest about the safety and efficacy of the drug?
The primary endpoint of their recently announced Phase IIa extension trial is "to establish continued safety and tolerability of ANAVEX 2-73," which is very vague. Can you discuss the use of this endpoint, and give us a better idea of how this will be measured?
Secondary endpoints include "exploratory cognitive as well as functional measures using Mini Mental State Examination (MMSE) and evaluation of Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL), respectively." Can you discuss these measures? Are they appropriate and clinically relevant?
What are important things to look for in the Phase IIa extension study?
There have been recent news stories that say patients on 2-73 have regained the ability to paint, play the piano, and showed other signs of reversal of memory loss. Can you discuss these findings and their clinical relevance? Is there anything in the data that supports these findings, or are these mostly anecdotal benefits?
What results from Phase IIa would we have to see for 2-73 to be successful in regulatory efforts? How do you view Anavex's chances of receiving approval for the product?
In