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Re: BonelessCat post# 100388

Tuesday, 09/30/2014 1:34:15 PM

Tuesday, September 30, 2014 1:34:15 PM

Post# of 146210
"We held the inauguration ceremony on July 21st. Since then, we have been working on special equipment fitout modifications, and preparing for facility validation. We have contracted facility validation to a third party which is expected to commence shortly. We plan to move our operations to the new facility in phased manner over the next several months. This is necessary in order to keep current projects undisturbed. We will need to move our existing equipment, as well as install additional equipment at the new facility. We will need to test and validate each piece of equipment. We will need to validate, test and verify that all the systems are functioning as needed for being able to make cGMP drug substance batches. Then we will need to run several batches, analyze the resulting products, and establish that our manufacturing processes are performing satisfactorily to produce the desired drug substance. A minimum of two reproducible batches are required to be made before submitting an Investigational New Drug application (IND) to the US FDA. In addition, we will also need to seek and obtain US FDA registration as a cGMP facility.

"The facility was inaugurated on July 21, 2014, by Honorable Congressman Jim Himes as the Chief Guest ... We are now completing the special equipment fit-out modifications."


Sure sounds like equipment coming way past June 30 to me.
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