RCE recce pharmaceuticals ltd

Not sure it was ever specified Crabcancer - although my...

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    Not sure it was ever specified Crabcancer - although my assumption had been they were working with an existing facility - which would still come at no small cost for what they want to do.

    In part this is from the Recce announcement in May 16;

    Reassuringly, within Recce’s laboratory in Perth, the preparation of RECCE® antibiotic 327 has been repeated (including all quality assurance checks) by a technician who was not associated with the invention;

     This technician will now initiate the product’s pilot-manufacture in a laboratory in Boston, USA where essential infrastructure, raw materials and proximity to the FDA are much more available than in Australia; this initiation is estimated to take about 3 months – and completion of the automated pilot-plant (for which tenders are currently being called), about a further 9 months;

     Recruitment of a chemical engineer, and assistant in the USA, both by mid-June 2016; they will ensure that the final product is produced in the pilot-plant to ‘name-plate’ standard, and continue to refine the already highly economical manufacture process of a little over 1 hour;

     The laboratory in Boston will be set-out and established at Good Manufacturing Practice (GMP) standards – and in order to aid Recce’s progress to approval, it is proximate to the FDA;

     At a compulsorily higher standard for safety (than efficacy), the Boston pilot-plant will produce RECCE® antibiotic 327 for tests of SAFETY (consuming about 60% of the budget, over approximately 1 year). This comprises multiple, separate, acute and chronic, detailed tests in rats and other animals to reveal dosing and pharmacological patterns of action of RECCE® antibiotic 327;

     In cooperation with Recce’s expert consultants in Boston, Recce will present and negotiate re all data for IND approval – the “passport” for subsequent testing of RECCE® antibiotic 327 in humans;
 
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