The eIND: Good Theory, Little Substance
Biotechs, by all logic, should be embracing the FDA's exploratory IND program, which theoretically allows companies to test compounds in humans with far less than the usual amount of preclinical data. They're not. The program favors large companies-and mostly those racing to develop chronic care treatments in hotly contested areas.
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The impact of FDA's Final Guidance on the use of Exploratory IND Studies could be profound for firms ranging from start-ups anticipating their first human drug tests to Big Pharmas with thousands of leads to manage and prioritize. Some service organizations may also benefit from the new regs, which may prompt an early clinical assessment of increasing numbers of compounds.
Perrigo’s clinical trials on CBD likely will take years before resulting products help bring order to the market. During earnings presentation, CEO Murray Kessler says the trials aren’t intended to establish claims for CBD but are more a long-term effort to provide data to FDA.