Well, from what I understand, the three main issues in the immunotherapy field that the FDA is looking to address is:
- The multitude of biotechs with a "me too" mentality is evidenced by the crowds in clinical trials - money is being invested by each and every biotech company on their particular technology (and in a lot of case
- Cytokine release (a major side effect) of immunotherapy remains a challenging issue and needs a resolution
- Cost of immunotherapy (on a cost-per-patient basis) is exorbitant because of the cost of cell manufacturing
In other words, the very issues that the FDA now realises needs fixing in an industry moving two fast by individual biotechs applying old technology is screaming out for universal platforms that fix the above issues. OMNICAR and CELLPRYME do that.
We need to stay ahead of the wave in order to maintain priority position. its more than apparent that SYC knows this and alludes to this when he speaks about the FDA changes. We are not in the pack all vying for a position on the wave... nor do want to be. I believe we are in the right place at the right time with OmniCAR and CellPryme. Both PTX100 and 200 have excellent safety profiles and PTX100 has every chance of progressing to a pivotal study (with the luxury of the choice of two indications). PTX200 on the other hand has bestowed the team with the technology to produce CellPryme-A. Who is to say that another company won't want do a "farm-in" on PTX200 for a stake in that asset?
I also think some posters are missing the significance of our collabs with the best of the best. Look at what Thermo Fisher have just lauched in Singapore....
https://finance.yahoo.com/news/thermo-fisher-scientific-launches-cell-030000626.html?guccounter=1
I love that the VP of our Scientific Advisory Board has family in Singapore and loves eating! It prompted me to check out what's going on over at Linkedin! Woohoo!!!
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