Thoughts on the Shareholder Meeting: Part 1
Overall impression:
I thought this was a very positive and informative meeting. The problem with having meetings every 18 months or so, is that there is a lot of information that has to be crammed into the brief meeting, and not all questions can be answered, or answered thoroughly. (many of mine were not)
After the last shareholder meeting, I came away knowing that it’s still going to take some time (more than a year) before commercial production begins as they still had a lot of prep work ahead, and hadn’t even started on the ground work, ie. construction on the grade-C cleanrooms, ordering the GMP Flaskworks equipment, increased staffing, or even starting on a pricing model required for reimbursement. Nothing happens quickly in this industry, and often many steps are necessary well before results are seen.
After this shareholder meeting today, I came away with the distinct impression that they definitely didn’t think that they would still be waiting this long for approval, and they are finally ready to begin moving forward with commercialization, new clinical trials, building partnerships, and Linda outlined a few areas where the ground work has already been laid. They are definitely acting like a company that is anticipating DCVax approval no matter what their forward looking statements said.
On the MAA and future applications:
Not much information could be given on the current process with the MHRA except that they are still in the Q & A process until they aren’t. While it sounds like Canada and the US will be the next applications filed, I personally doubt that we are going to hear much about either in the near future. I think Linda only discussed it because it’s a reasonable question that was asked, and while that may be the current plan, I just don’t think additional filings will happen until maybe the end of the year.
They really don’t want to bite off more than they can chew, and it sounds like the initial manufacturing in the US is only going to be for investigational use for Dr. Kalinski’s polarized Alpha DC1 in connection with the University of Pittsburgh. It will probably take the first half of the year to get manufacturing up and running in the US again for Dr. Kalinski’s clinical trial, which seems to be the immediate priority since there are development obligations with the licensing agreement (which was signed eighteen months ago).
Commercial manufacturing for DCVax-L in the US will be a much larger undertaking, and will require considerable funding, a large facility, close to a year for technology transfer to the new facility, additional equipment, additional staffing, dedicated leukapheresis facilities, etcetera, etcetera. I think this is why Linda made it a point to say that “commercial production will take place at the Sawston facility.” They simply are not ready to support a marketing application in the US and Canada at this time (unless there is a partner or licensee).
It doesn’t surprise me that the EU wasn’t mentioned in the marketing application plans as initial production in the simplified Grade C lab at Sawston will barely handle the demand from the UK. They probably won’t be able to apply for marketing approval in the EU until after they have the funds to build the two large C labs that were previously put on hold, and construction on those will likely take at least a year.
Clinical trials:
AI
