Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Repros At A Loss After FDA Abruptly Cancels Enclomiphene Panel Review

This article was originally published in The Pink Sheet Daily

Executive Summary

Real reason behind cancelled Nov. 3 advisory committee meeting relates to secondary hypogonadism indication, company says, not concerns about analytical validation as FDA claimed.

You may also be interested in...



Valbenazine FDA Panel Cancellation Is A Good Sign, Neurocrine Says

US agency's decision not to hold a February advisory committee review of tardive dyskinesia treatment viewed positively by Neurocrine, which emphasized quality of its communications with the review division and the drug's breakthrough therapy status.

FDA’s Tough Stance On Patient-Reported Outcomes Underscored At Repros Meeting

US FDA advisory committee's insistence on symptom benefit as an efficacy endpoint for obesity-related secondary hypogonadism highlights importance of Repros' current efforts to lay groundwork for a patient-reported outcomes instrument for further study of enclomiphene.

FDA/Industry Dispute On Hypogonadism Drug Efficacy Endpoints To Get Panel Review

Clinical trials should go beyond merely demonstrating maintenance of spermatogenesis, US FDA says, but drug developers assert an increase in serum testosterone levels and/or improvement or maintenance of sperm concentration are appropriate clinical measures to support approval.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS077943

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel