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theswordman

09/21/21 7:34 PM

#185269 RE: Emergcy #185251

I agree--but some companies do not. This biotech gave their CEO the boot and he had gotten them 2 FDA approvals. Started talking about secondary ETC and they fired him

https://endpts.com/aerie-fires-ceo-after-lead-program-flops/
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Things took a sour turn more recently, however, after Aerie revealed a mid-stage study did not hit statistical significance last week.
The dry eye disease trial missed all of its primary endpoints, but Anido asserted the endpoints were “not required” because the trial is a Phase IIb study, a statement that rankled outside observers and investors.

yowser

that_little_voice

09/22/21 9:38 AM

#185347 RE: Emergcy #185251

Wrong, Phase 2 is dose escalation to see which dose produces a positive effect.

Then you run a phase 3 in a larger size to confirm phase 2 results dose.

Phase 2 LH trail failed. They are going to run a phase 3 with a failed trial/dose?

Your comment suggests every drug moves to phase 3 regardless of phase 2 read out which everyone knows is not accurate.

This may be of interest to you

https://www.bio.org/sites/default/files/legacy/bioorg/docs/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf