Tuesday, December 01, 2015 6:50:25 PM
In addition, regarding my other points about Cognate, here is what I do know and that Cognate has proven:
1. Cognate’s facilities adhere to cGMP standards. Yes, this is expected, but it still costs a lot of money, expertise, and on-going maintenance. ARGS is still under construction.
2. Cognate has been working with European partners regarding negotiations with Unions, transferring key process knowledge, and ensuring regulations are adhered to from a production standpoint.
3. Cognate has been working with all of the existing clinical trial sites and has established new methods of transporting cell therapies. In addition, Cognate continues to come up with new solutions that decrease the variable cost for developing therapies (i.e. Batch Processing). ARGS has existing process in place. But those existing process will be non-existent in the coming years once their new facility is completed. ARGS will have to re-invest to build out a brand new supply chain with new partners. That costs a lot of upfront cash … again.
4. Cognate has maintained the facility well and continues to pass FDA audits (else, not sure how they maintain their cGMP status).
Here is the only thing that still has not been proven:
1. Cognate has successfully scaled out the production environment to support a commercial launch of DCVax-L. This will not be fully proven until DCVax-L gets to the market (if it ever does).
Of all the points I’ve highlighted that differentiates Cognate and ARGS, there are 4 where it is proven and only 1 that is unproven. ARGS will get to where Cognate is, but who knows how long? At least we have something proven.
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