Does this mean, that after it has gone through Phase III, they will be able to improve the process by increasing the number of Peptides without needing to go through the 3 phases of trial a process again?
(c)(1) A change in the manufacturing site or a change in the manufacturing process, including a change in product formulation or dosage strength, beyond the variations provided for in the approved application.
Seems like they might have been wise enough to cover all the bases ahead of time.
Are we going to learn more about masking at some point in the near future?
You're right NHE, Sheba's in phase III http://tinyurl.com/2rjrwf and Tovaxin is in IIb with plans for a III if all goes well.NHE wrote:Tovaxin is actually in Phast IIb if I remember correctly.
As Lyon noted you are correct, my concern is that no matter if its in Phase II OR Phase IIB, it still has to start and go through a Phase III period, which will delay its coming to market, as compared to something already at that stage.NHE wrote:Tovaxin is actually in Phase IIb if I remember correctly.
Thanks Tim, I hadn't noticed your response earlier. I wait with baited breath, or does my wife say that my breath smells like bait??IHaveMS-com wrote:This is a true statement if you remove the word near. I have run out of steam for the moment. I will have my Great American Novel completed at least 6 weeks before the first person finishes the IIb trial, mid-September.
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