@starcahier 2 months ago
ImmuCell pauses Re-Tain after FDA setback, pivots to First Defense expansion
ImmuCell pauses Re-Tain after FDA setback, pivots to First Defense expansion
ImmuCell received an incomplete letter from the FDA regarding their Re-Tain application. The rejection stems from deficiencies at a contract manufacturer's facility rather than ImmuCell's own site.
Because of this delay and an expiring contract, they are pausing further investment in Re-Tain and taking a $2.3 million non-cash write-down in Q4. The company is pivoting resources to their First Defense product line, including a 50% increase in sales staff and repurposing equipment. Management noted First Defense generated $27.8 million in trailing twelve-month revenue.
@Simonwhite 2 months ago
It's tough to see face an FDA setback, but pivoting to First Defense sounds like a pragmatic move to protect resources.
