Validation is when the production line is first installed (fully installed) - it has to go through some production runs and a pile of I don't know what. The 60M prod line took 3 mths. My take even if they moved the line 2 metres it would have to be validated again. I read that about another company. The point about June Sept is for the next line mid 2013.
I believe the stability trials take two years. It also takes a couple of months (2-3) to get approval from the FDA for the device and drug combination. Don't know if the couple of mths is included in the 2 yrs - very much doubt it.
The two stability trials we know about only started July last year (13.5 mths ago)- pharma A. has signed an agreement already - so they feel their trials are going OK by the look of it. pharma B (should be the big one) we are all waiting for plus another one before Xmas.
The products used which come in contact with the drug are common every day materials, so it has been said there will be no problem getting through the trials.
It has been said that if a company wants to have a drug in a syringe, packaged and ready to ship and sell as soon as they get FDA approval then they starting ordering in syringes 4-6 mths before so as to get them ready for sale.
They could sign an agreement next month and not take delivery for 3 4 6 mths.
It has been one big waiting game since we heard about these trials.
UNS Price at posting:
49.0¢ Sentiment: LT Buy Disclosure: Held
