next week or month - what's the difference, page-12

The Gavel, quit trying to pass yourself off as some sort of authority or knowledgeable person with regards to how things are done or proceed with the FDA. Firstly you have been caught out on numerous occasions on these threads showing your lack of understanding about what ACL even do or who they are associated with, the deals/partnering they have in place. Then once someone here educates you and corrects you about the false statements you continually make, you use that new found knowledge, or fact, and then try to find an angle with the new information you have learnt from others to try and downramp once again.

Your see through, most time wasting trolls that I have seen at least take off once they are exposed as nothing more than an uneducated (on the topic they are discussing) stirrer trying to get a rise out of others all the while not really knowing any facts, unfortunately it is not the case here.

The decision would never happen on site in India (at the Fill/Finish plant), the FDA representatives who probably flew from the US to India to inspect were there to inspect not only Fondaparinux fill finishing but a few different drugs. The FDA has also strung them along with supposed inspections to happen in June/July, then changed to Sept/Oct and then to November, how on earth is any management team supposed to be able to know what is going on and exactly when the inspection is to happen and more importantly when they will (FDA) get back to them with regards to any approvals when they seem to run their own clock and push out dates like that.

There may have been a query that needed to be addressed on any number of their drugs filled in the plant (it's a 3rd party to ACL & RDY), it's not a case of FAILED Your Out, they would have to address the issue with a solution that FDA is happy with, I'm certainly not saying this has happened but your once again silly comment that "The decision to issue or not issue will have been made by now and management will be in receipt of such a decision I am sure" is both misleading and absolute bollocks. Get a grip on reality and quit trying to mislead others, it could turn around and bite you back one day.