The method used by Phyton utilizes transformed plant cells instead of bacterial cells (E. coli) to generate the protein of interest (IGF in this case). The bacterial approach is used everyday by most labs in the country to generate protein of interest. It is a very simple ans standard methodology. It appears that Phyton specializes in production of protein via plant cell host. Since this is their area of specialty, it should not be difficult for them to apply same methodology to produce large scale of IGF or any other protein of interest. FDA will not require new trial. They will however will want to verify purity of the product and the commercial plant fromwhich IGF is produced. IMHO, it comes down to revenues and profit- if Phyton will be rewarded appropriately for their efforts, they will be able to fulfill the needs of INSM relatively quickly- question is how much is INSM willing to share with Phyton.
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