I don't think the ABPM and phelbotomy studies will be an issue for Lopicine. I also don't think the stopping criteria will be an issue.
Even though Tlando can't be titrated, knowing when to pull a patiet off of a drug is a definable process. In my humble opinion the FDA will want a more realistic timeframe and process for identifying when to take a patient off of Tlando if his TRT levels can't get and stay within the reqired range within "X" period of time. In my humble opinion, of the four elements stated in the CRL, resolving the agreed upon secondary endpoint issues might be the trickiest aspect to fix to the FDA's satisfaction.
Recent LPCN News
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- Form 8-K - Current report • Edgar (US Regulatory) • 11/01/2023 01:31:11 PM
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