RE:RE:RE:PrinceOfCut only works the day-shiftGet real....maybe you should review this
Telesta's BLA submission has been made following extensive and continuing dialogue with the U.S. FDA, including a formal pre-BLA meeting in November, 2014, and a Type C facility meeting in February, 2015. As part of this process, Telesta has incorporated the FDA's recommendations into the current submission and the company has also been working with top-tier regulatory consultants to ensure that their BLA submission meets all current regulatory requirements.
Concurrently with this BLA submission, Telesta confirmed the completion of a number of upgrades and improvements to Telesta's manufacturing facility and operating procedures, undertaken following recommendations received from the FDA at the Type C facility meeting held in February. As previously announced, these improvements were implemented by Telesta to ensure that its manufacturing facility is well positioned for the FDA preapproval inspection that will take place as part of the FDA's formal review process.
Sorry, but Santa is no longer running the company. We now have management that actually understands what it takes to make a submission to the FDA. That’s why they have had “continuing dialogue with the U.S. FDA” and “have been working with top-tier regulatory consultants to ensure that their BLA submission meets all current regulatory requirements.”
Go back to your hole….by the way you just earned another ignore.