Post-AGM Discussion with Management Comments from Attendees
rjc
> I missed most of the AGM, but did arrive for the end of the Q&A, and participated in the talks with Brad and Matt after the more formal presentation.
> After the meeting, Matt was clear that it was two suitably structured randomized Trials that the FDA require, rather than two Phase III Trials. On this basis, all 6 of our current randomized Phase II Trials, plus our 167 patient randomized Phase III H&N Trial can function as the first of two required Trials across the covered indications. Matt also said that the second randomized Trial in a given indication might not be required in Europe for a conditional approval.
> Matt recently received additional information on this, and it was recommended that Matt get over to Europe to speak with the regulators there to get things moving, based on the randomized results that Oncolytics now has, or will soon have. Because of this, Matt will be in Europe next week.
> From what Matt and Brad said separately, and in combination, I think it might be possible that the Big Pharmas that are taking an interest in Oncolytics could influence the choice that is made as to which of the current 7 randomized Trials will be the basis of the selected next (follow-up) randomized Trial.
> rjc
------------------------
Dr Coffey will be in Europe to build relationships and make sure all European requirements for provisional registration are understood and complied with.
Europe requires ONE well-designed, well-controlled, randomized trial with good results for provisional approval and the start of Reolysin sales there. FDA requires TWO independent, randomized, well-controlled trials, each with good results for approval in the US. Phase II trials count if they meet all the criteria above.
Matt wants Oncolytics to be ready to file in Europe WHEN the results of any of our seven randomized trials are complete, un-blinded, and analyzed for statistical significance. Knowing the European regulators and their processes are important too, so they know you when you walk in with trial results, asking for provisional registration.
In after-AGM conversations Matt was clearly excited by this quicker (but rigorous) approval path in Europe, and eager to make it happen efficiently whenever "event driven" un-blinding occurs on any of our seven randomized trials.
Camelcoat43
--------------------------------------
I thought BT gave a good presentation.
I was a little put off by his answer to the question about what triggers the unblinding in the H&N trial. He seemed to say they haven't completely figured it out yet. That will leave him open to charges of incompetence.
He was also a bit testy when a questioner correctly pointed out that the company has enough information from the 6 week response unblinding to know which group some of the patients are in.
No deal yet with the sketchy Russian company but they have been in talks. Do we really want a deal with a company that issued a false press release?
daveau79
--------------------------------------
starsearcher40
> First off, I think management did a good job at the AGM. It's a double edged sword that we expect the company to make prudent and measured steps (which for the most part they do), and then have to wait (prudently) for the information we want to arrive. Brad was not going to jeopardize any of the trials, and on a number of occasions said that he would not divulge certain information at this time. This was the (only) correct move.
> What I liked the most from the AGM was the comments regarding Europe, and that Matt was on his way there on Monday to meet with Regulators. If the company is able to recieve regulatory approval based on the current studies, then this is an absolute game-changer. Approval equals cash flow, and cash flow is vastly important. Sure, they can get this through further dillution which no one likes. But with real cash flow from an approved product, dillution evaporates as an ongoing issue. European approval also lends a vast amount of credibility to the product, and as such, a vast amount of interest from the investment community.
> People think we're going to be waiting a long time here. Quite the opposite, I think things are going to be moving fast on several fronts here. For those who sell, or move on from a certain fatique of waiting thusfar, all I can say is I strongly believe you'll lose twice...once on the initial depressed sale, and then watching thosee who stayed the course, win in spades multiple times over.
--------------------------------------------
