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Thursday, January 22, 2015 9:50:55 AM
As I've stated since 2012 ~~~ THE REAL $$$$$ ~~~~ COMES IN 3-5 YEARS.....MEANING 2015 --- 2017.
You have 3 items that cannot be overlooked right now.
1) Obtaining essential patent protection in Canada....after the US they are next large consumers of pain relieving opioids. Would love to hear more about their additional foreign ART patents. The first Canadian patent came without warning.
2) Increasing the size of the commercial scale fluid bed processor from a capacity of approximately 200 kilos a batch to 1000 kilos a batch. Means a big in production is expected and we know that means their first ART opioid launch is coming.
3) The hiring of Dr. Kenneth Smith who held the position of Chief Intellectual Property Counsel for Alpharma where Nasrat previously worked and from where Pfizer obtained the patent rights to Embeda.
BUT DON'T TAKE MY WORD FOR IT....LET'S LET NASRAT DO THE TALKING!!!
Let me summarize a couple of high level points that the staff mentioned already. First, the commercial launch preparation; we are upgrading the facility and we’ve purchased multiple equipment, includingwhatDoug just mentioned, a fluid bed that increases the capacity by multiple folds. We’ve hired the necessary senior management to lead; our Legal by Dr. Ken Smith, Scientific Affairs -Dr. Jason LePree and Regulatory Affairs -Dr. Sophy Abraham. This new addition is to complementour already existing management team; with --and our pursuing different sales and marketing models and that’s one of the reasons I’m on the west coast. Our R&Dactivities on pipeline are very rich; we have several active R&D projects. With a small company like ours you need to prioritize and not take on too much. But we have more than a half dozen that are active. Our focus remains on ELI-200.ELI-200 has undergone vigorous testing and clinical trials and lab trials this year. We definitely have a successful formulation and technology. We have passed the B.E. test, we are bioequivalent; we have placed 4
registration batches on six month accelerated and twelvemonth room temperature stability. The six month accelerated and nine month are done. The twelve month will come out next month and the data looks solid. We filed an IND and havebeen in constant communication with the FDA and are receiving feedback from them. Our anti-abuse FDA guidelines have been implemented. I hope to the satisfaction of the FDA. In future levels the abuse testing was completed and the reports issued. The Liking study, the HAL study; category two is completed and category three is completed with excellent results. The FDA has seen quite a bit of the data and the data they have seen they are happy with; and the rest of the ( --) they had nothing but positive things to say about it, especially on the CMC part. Everything we presented to them they were in agreement with it.
Fear Uncertainty and Doubt FUD It Ain't Going To Work Here Anymore. Notice the lack of question mark.
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