Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

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

Per a fiercepharma article comment from Cantor Fitzgerald analyst Alethia Young

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.”

Yep, it seems that Spectrum didn't have good Control of the manufacturing process. That's their job.

The same article noted

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

That's 13.75% of a 4B market. I'm not greedy. I'll take 10% of a 3B market or 300M.