THIS TIME PMCB + AN WILL GET IT RIGHT
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M.Lohr's P1/2 clinical trials are very detailed and impressive , I am sure FDA has already been reviewing ...And , the Lohr trials are included as part of PMCB's current US and World Patent Apps , currently under review , and available to the public to read )
PMCB's patent Attorney is Pepper Hamilton
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"The fund raising will enable Austrianova to complete Phase III trials for ‘NovaCaps®’ and finance further partnering projects to develop other therapeutic approaches on the basis of its cell encapsulation technology. Austrianova’s reference product ‘NovaCaps®’ is the first encapsulated cell product targeting solid tumours that are difficult to treat. ‘NovaCaps®’ has received orphan drug designation from the European Medicines Agency (EMEA) for pancreatic cancer, a cancer that is currently the least well treated cancer indication. Austrianova is currently commissioning a GMP manufacturing facility for ‘Novacaps®’ in anticipation of obtaining Marketing Authorisation for the product in 2009/2010. Austrianova’s ‘Novacaps®’ treatment for pancreatic cancer has successfully completed Phase I/II clinical trials. Phase III trials are due to commence in early 2008. Trials of 'Novacaps®' for additional indications, including the treatment of liver cancer, head and neck cancer and ovarian cancer are due to commence in 2008."
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"Vienna, Austria (PRWEB) May 10, 2006
Austrianova Biotechnology sets up unique industrial manufacturing process for the GMP compliant production of encapsulated living cells.
Austrianova today announced that it has started industrial production of its lead product NovaCaps®. Austrianova is the first company worldwide that has been successful in developing a market scale, GMP compliant, industrial production process for encapsulated cell products. The implementation of the proprietary and unique manufacturing plant was realised with an investment of 6 Mill. Euro and took two and a half years. Austrianova’s GMP manufacturing plant has a capacity of 40,000 vials per year, sufficient to meet the projected demand for NovaCaps®. Contract partner, Miltenyi Biotec, supported Austrianova with expertise in the area of GMP production of biologics as well as providing GMP compliant production facilities in Frankfurt, Germany."
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"Limerick investor takes big stake in drug firm
Mon, May 21, 2007, 01:00
Limerick-based Ryan Group Holdings, which is headed by pharmacist Gerard Ryan, has taken a significant stake in Vienna-based Austrianova Biomanufacturing.
This is the first step in a series of fundraisings for Austrianova that is expected to net the biotech company more than €35 million in the coming months.
The size of Mr Ryan's investment was not revealed, but was described as "multimillion euros"."
AI
