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Investor2014

09/21/23 9:59 AM

#431999 RE: WolfofMia #431991

Your premise is still incorrect.

1) Traditional approval is nice, but we are SAVING MILLIONS and improving our odds of approval this way!

2) Our trial design being way more robust than our competitors, we didnt cherry picked the patients, we have the same odds of approval or way higher due to our efficacy vs safety profile.

3)You can go for a P3 and pay out of your pocket for the additional evidence needed.


All 3 statements above are flawed;

1) because by not running the ordinary often more than one P3 trial(s), the company is taking a calculated risk of achieving quicker revenue generation and could instead find that the P2b/3 have turned out to be P2b trial with strong signals rather than a pivotal P3 trial for traditional approval. If AA great, if not back to square one designing and running a large P3 trial extending the time to market compared to having done it right first time.

2) Here you are extending in your own mind Anavex trials to be more glorified and cunning than they probably are in reality. So far we do not have enough detail about the P2b/3 trial to know if your thinking is correct or just a dream induced by WGT and TGD bias.

3) I don't foresee any near term future where biotech companies would generally be picking up on this advice of yours.