Avid Bioservices Inc (CDMO)

[biopharm]

Wonder if Laura Benjamin gets to sit in on any FDA meetings regarding betabodies or other PS Targeting activities because now since she must realize how sabotaged the prior PS Targeting trials were, it is very simple to conduct biomarker readings on all patients throughout any trial. Seres knows how to adapt and work their FDA channels but will Laura Benjamin be allowed to by the puppet masters behind David Malek?

It certainly looks like Joseph Carleone could care less about shareholders at this time and too busy talking with Louis Gerstner friends

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Seres Therapeutics has unveiled the design of a phase 2 trial it thinks could secure FDA approval for its once-failed treatment for recurrent Clostridium difficile infection. The microbiome pioneer emerged from talks with FDA saying the regulator agrees the study may qualify as a pivotal trial if it achieves a â??persuasive clinical effect.

Cambridge, Massachusetts-based Seres went into talks with FDA earlier this year armed with its analyses of what went wrong in the earlier phase 2 which missed its primary endpoint leaving a lasting dent in the companyâ??s share priceâ??and its proposals for designing a better follow-up study. At the time, Seres asserted the trial failed because it misdiagnosed the C. difficile infection status of patients entering and during the study and gave subjects a suboptimal dose of SER-109.

Now, Seres says FDA agrees with its analyses and plans to avoid the same pitfalls in the next study.

https://www.fiercebiotech.com/biotech/embargoed-until-7am-et-after-fda-talks-seres-unveils-potentially-pivotal-trial-for-once