CA, please excuse my ignorance but, does that mean one more test to complete or its already completed and the company is doting their "I's" and crossing their "T's" so we can file?
Are there any other tests besides the pyrogenicity tests? For example someone here once mentioned Stability testing. Are we going to need Stability testing as well?
Maybe someone in good standing with IR could ask, " What are the remaining tests left that are required before we file IND?". I have run my course with these people.