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Replies to post #2562 on Spectrum Pharmaceutecals Inc (SPPI)
antihama
03/18/19 9:21 PM
#2563 RE: antihama #2562
Regarding tech transfer, you want to validate the test methods (ID, critical manufacturing tests), validate 3 manufacturing runs, putting samples from those manufacturing runs on stability (for testing later), storing Retain samples from each batch, validation of shipment of product under controlled conditions etc. That's just a normal part of doing business. - previous post
The company didn’t say in its announcement what specific information the FDA needed, but Cantor Fitzgerald analysts spoke with management about the delay. In a note, analyst Alethia Young told investors: “When we asked for clarification on the sort of new CMC data they need to generate, they noted an example around shipping validation.”
Jefferies in an investor note called the “program that anchors the company and leverages management expertise.” It has estimated annual sales to reach $550 million