Wednesday, December 02, 2015 12:27:31 AM
With regards to factual items about ARGS:
1. ARGS only recently began construction on their new manufacturing facility for commercial production. Thus, it is impossible for them to begin scaling their current production. This new manufacturing facility is designed to replace whatever facility they are currently using. Thus, it is logical to conclude that ARGS's current facilities do not have the capabilities to scale or expand production and is at capacity. Hence, ARGS's need to purchase additional land for a brand new manufacturing facility. (Source: ARGS Most Recent 10-K, pg. 21).
With regards to NWBO and Cognate, expansion of manufacturing capabilities is taking place at the Memphis facility. Thus, the Memphis facility definitely has the potential of producing initial commercial volumes of the DCVax products. This facility is owned, managed, and operated by Cognate.
As ARGS has just initiated construction of their new manufacturing facility, I cannot see how ARGS can be further along than NWBO.
Not comparable.
2. ARGS's does not contract out manufacturing services. ARGS's contracts out the development of automated production process to 2 independent firms, Invetech and Saint-Gobain. Invetech is responsible for creating the automated production process and equipment for creating ARGS's product. Saint-Gobain is responsible for creating all of the disposables that will be utilized by the process to produce cell therapies. That is completely different from contracting out manufacturing services. ARGS, not the 2 partners, will be responsible for setup, execution, maintenance, and future development of their manufacturing processes. (Source: ARGS Most Recent 10-K, pg. 12)
NWBO contracts out manufacturing services to Cognate. Cognate is responsible for not only developing the automated production process, but also its setup, execution, maintenance, and future development.
In my opinion, this is extremely beneficial to NWBO as Cognate will continue to invest and improve the manufacturing process. This is possible as Cognate has a separate cash account from NWBO and different business objectives. Hence why as shareholders we continue to hear improvements in the overall production and delivery process. ARGS does not have this luxury. ARGS will be constrained by their cash resources and once the production system is sufficient to pass FDA guidelines. I believe additional investments will cease until ARGS sales have increased to a point it can sustain operations.
Thus not comparable between NWBO and ARGS.
For your other comments, I've stated in my previous post where I've listed out all of my points that the only truly unproven portion is Cognate's ability to produce commercial volumes. This is something NWBO has stated Cognate and them are working towards and preparing for. In one of their past prospectus, NWBO has stated that Cognate's Memphis facility has the space to increase capacity to service 5,000 patients annually. This capacity increase will occur on an as needed basis. DNDN launched their Provenge product with an initial manufacturing capacity of 2,000 patients annually. This is the link to the filing where these numbers are stated: http://www.sec.gov/Archives/edgar/data/1072379/000114420412067286/v329695_424b4.htm
Cognate has the space to expand (primarily clean room), ARGS clearly did not. The only thing that has not been proven for Cognate and NWBO is that all of the equipment needed to expand capacity to service at least 2,000 patients annually is in place.
For ARGS and other BioTech companies, I find it difficult to believe that outside cell therapy contract manufacturers would shoulder so much business risk for the opportunity to produce treatments that have yet to record sales. It makes no sense to build out a large production line for a product that has not yet been approved for the marketplace. Thus why all of these BioTech companies are forced to build their own manufacturing facilities and contract out the development of the equipment and processes. Hence why I believe NWBO's situation is so unique and such a large competitive advantage.
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