DMD Gene Therapy - Pfizer Inc, page-4

Wayne

2-3 weeks ago I noted a kind of news flash on my screen indicating that Pfizer had got $70 billion for their COVID vaccine sales. It would be $US with certainly plenty more to come. Ironically, on the Rare-Disease-Day Webinar 3 months ago the Panel Members who I consider are involved in work most closely related to our interests reported that, in addition to having had to spend 80% of their time on the COVID crisis requirements, losing access to research labs they normally use for 6 months, losing research staff permanently due to lockdowns etc., they also had budgetary cuts imposed on them.
With that magnitude of funding available I can't see Pfizer having any problem whatsoever making ANP an offer they couldn't refuse if they consider we have something that just may, perhaps, could useful to them ?
Regarding the FDA, from what I heard at the Webinar they must still be months behind with their regular scheduled activities, and the COVID work is still continuing, so I can't see our submission moving with any urgency.
I mentioned the budgetary cuts because of the irony - The U.S. government, plus ours and those of all other nations taking the vaccines are vastly enriching the largest maker, but cut the budget of the government agency that is playing a vital role in making it available. And this may be a clue to what the FDA means by getting into co-operative partnership arrangements with their clients - we are taking that to mean they want to help us, but doesn't it mean we will help each other ? One of the FDA directors on the Webinar provided the only reference to what may be co-operative partnerships that I could find when reporting that his division had been able to partially cover their budgetary cuts - "we have created a pre-competitive collaberation to provide additional support to study ..", which he goes on to explain were pre-competitive partnerships which involved 3 pharmaceutical companies who joined in to sponsor the study to help defray the additional costs of adding extra sites etc. to speed-up the data collection work.