It’s better to ask Todd or Joe, but yes I believ

It’s better to ask Todd or Joe, but yes I believe Generex is exactly correct. They also don’t want an ING process that is lengthened by not meeting known criteria resulting in a tedious path to IND approval. See:

Drug Substance Requirements for INDs
• Description and characterization
• Manufacturer(name,address,contact
information)
• Generalmethodofpreparation/synthesis
• Specification(tests,analyticalproceduresand acceptance criteria)
• Batchanalysisdataforclinicaltrialbatch
• Stability(throughendofclinicaltrial)

https://www.fda.gov/media/84917/download