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Saturday, March 02, 2024 7:03:15 AM
"A pre revenue company has just announced that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) agreed that the companies drug is eligible for submission of an application for a Union Marketing Authorisation in the EU under the centralised procedure. How often would it be that such a company would not then submit an application?"
Chat GPT - "It would be relatively uncommon for a pre-revenue company to announce that the CHMP has agreed that their drug is eligible for submission of an application for Union Marketing Authorization in the EU under the centralised procedure and then decide not to submit an application.
Receiving eligibility from the CHMP is a significant milestone indicating that the drug has met certain standards of safety, efficacy, and quality required for submission. Typically, companies invest considerable resources, time, and effort to reach this stage in the regulatory process. Not proceeding with the application after such an announcement would be unusual, as it would mean foregoing the opportunity to obtain marketing authorization in the lucrative EU market.
However, there could be exceptional circumstances where a company decides not to proceed with the application despite receiving eligibility from the CHMP. These circumstances might include strategic shifts within the company, unexpected developments in the market or regulatory landscape, or significant challenges in the drug development process that make further investment untenable. While such cases are possible, they would likely be relatively rare compared to the number of companies that proceed with the application after receiving CHMP eligibility."
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