It seems to me the deeper we go into September before an announcement on 190 PFS, the better. That would seem to imply less people dying on TDOX. Some are seeming to imply such an outcome would mean the control arm (RFA only) is working better. However, outcomes with RFA are much more predicatable per years of use. The TDOX arm can be the only significant variable in the equation.
Stocks, what's up dude? I will be in Vegas for 3 nights next week. When not by the pool I will be doing a little scouting for the big trip. I can check on your accomodations also. Do you prefer a hostel or vacant overpass?
No problem...btw, your second question is a VERY good one. I have no clue where we stand in terms of manufacturing. We should get some update by end of year, but I would think we still have some work to do in that area. For sure, I remember management saying they were hoping to have 3 suppliers by the time of approval, and they are having problems with one of them not being able to supply. So, they are in the process of securing a 3rd supplier I believe to support commercialization.
But, to answer your question, even if the trial is halted, they would not start selling right away. They would have to submit an NDA, which would probably happen 4-6 months after the halt, and within the NDA, there are all sorts of requirements around manufacturing/CMC. So, inevitably, they are going to have to get it all together soon enough.
btw, this omy guy just posts nonsense every chance he gets.
Lol...he posts an article from a single case report of 1 patient...and to add to that, he brings up points which clearly justify the rationale for the HEAT trial, and by talking about ablation margins, he is bringing up points that ironically are the very reasons why i strongly believe the trial will succeed.
As you can see, he is not the smartest of paid bashers, lol. Hence, the CONSENSUS opinion of the board to ignore Omyomy.
For a really great
and easy to read explanation
Read Here There is a link provided to the trial and it was published in 2010 (so very recent).
You are absolutely right in the sense that we have much more predictive power to estimate the RFA-only arm. Aside from management's insistence of 12M median control arm, lots of literature out there supports this, very clearly.
So, yes, assuming the control arm looks similar to these expectations, it should be better for the the Tdox arm. But, and this is a big but, Kid and others here correctly pointed out that the 190 may have happened a while ago, and that we are now waiting for confirmation of these events. So, in that sense, the longer we go from here doesn't mean much more, other than it is taking a long time to confirm the 190!
I'm optimistic as can be, I think the company has a real gem and SOC-game changer here in ThermoDox.