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| Alias Born | 11/23/2016 |
Wednesday, July 31, 2024 4:33:06 PM
The facts you got wrong you can check up on here:
And here:
That's all there is to the topic, which is that there are tolerability issues with administering A2-73. A good proportion may well be addressed by a different titration scheme, night time dosing etc., which the company have suggested.
No trials have been run yet that shows that these measures will work, produce less TEAEs and achieve statistically significant trial results per original protocol with ITT population analysis and accounting for any dropouts in the statistical methods used.
Whether EMA or other regulators will accept the existing trial results as registrational and then go on to issue some form of approval is yet to be seen. However, simply citing the Mab's risk issues, which are clearly real but by the FDA deemed manageable vs. benefit, is not the determining factor for approving A2-73. The Mabs were approved (only by the FDA) on solid data and statistics, but with an iffy balance of clinically relevant outcomes vs. risk. Anavex IMO currently lack the solid data, but may well in the end show a better risk/benefit profile.
And here:
That's all there is to the topic, which is that there are tolerability issues with administering A2-73. A good proportion may well be addressed by a different titration scheme, night time dosing etc., which the company have suggested.
No trials have been run yet that shows that these measures will work, produce less TEAEs and achieve statistically significant trial results per original protocol with ITT population analysis and accounting for any dropouts in the statistical methods used.
Whether EMA or other regulators will accept the existing trial results as registrational and then go on to issue some form of approval is yet to be seen. However, simply citing the Mab's risk issues, which are clearly real but by the FDA deemed manageable vs. benefit, is not the determining factor for approving A2-73. The Mabs were approved (only by the FDA) on solid data and statistics, but with an iffy balance of clinically relevant outcomes vs. risk. Anavex IMO currently lack the solid data, but may well in the end show a better risk/benefit profile.
The longer we wait, the sooner we will get rich!
