Monopar Therapeutics Begins Rolling Submission Of FDA New Drug Application For ALXN1840 Albumin Tripartite Complex Activator To Treat Wilson Disease
The FDA has authorized Monopar to submit the NDA on a rolling basis, allowing completed sections of the application to be submitted and reviewed while the Company finalizes the remaining sections. Monopar has submitted
Monopar is sending pieces of its medicine application to the FDA bit by bit instead of all at once, which can speed up the review process. This shows the FDA thinks the medicine might work, so keep an eye on whether Monopar hits its deadlines and what the FDA says when it reviews each part.
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