"You misread this."
I believe that I didn't and some points below may, to some extend, from time to time, at specific market conditions, support my belief.
To be eligible for Phase II trial patients shouldn't receive more than 10mg/day of prednisone and equivalent. It's interesting how many patients used 7.5<n<10 mg/day during Phase IIb trial. Or selection criteria were changed?
Some other disease-modifing drugs, for example methotrexate, should be discontinued before Phase II. These two categories of drugs seems to be the most effective standard therapy. So, to start treatment with the vaccine, patient should give up standard, and probably working, therapy for 2-5 months to get (or not) some improvement in future. Earlier limit was 10, now 7.5 mg, but, based on company belief, any prednisone dose may reduce treatment efficacy.
Let's look, for example, at previous Phase II. Of 99 patients enrolled into Phase II, 16 patients either initiated or increased their use of prednisone during the course of the study. 12 patients began treatment during the latter part of the study. 28 patients received 1 ore more joint injections for relief of joint pain.
Given such interesting prednisone-based hypothesis, wouldn't it be great to know an exact number of patients with >7.5 dose?
BTW, would you expect more patients using prednisone in severe or moderate cases?
What this PR told us? Phase IIb trial was completed. 340 patients treated. For patients using >7.5 mg/day prednisone treatment was not effective.
If only one patient used prednisone? If 339? How many completed the trial? What about doses? And, BTW, what does that mean statistically significant? Isn't it something that Chief Exec Statistician gut may believe to support? What about some traditional numbers?
Again, management may believe that results may support... But what about digital measure of their belief? More than 3 Mln $ insider selling last month, isn't it a good one? |
