Design of Phase III :
From looking at the results of the phase II trial, I believe it is in PARS' best interest to have more severe TBI patients (GCS 4-6) in the phase III trial.
Obviously, HU211 benefited this group much more than it did for the less severe roup (GCS 6-8). PARS should try to have more severe cases in its phase III trial. This way they will be able to prove eficacy with a smaller number of patients. 38.4% of the severe cases who got HU211 reached good outcome (on the GOS) within 6 months, compared to just 13% in the placebo group, that's a major difference.
BTW, They did mess up with their PR work, as almost nobody knew this number until market closed on Wednesday. The headline of the press release should have read something like this : "Successfull phase II trials; HU211 significantly lowers ICP without causing low blood pressure; In severe cases, 3 fold increase in HU211 patients achieving good outcome vs. placebo"
Getting the 3-fold number to the press, and repeating it over and over would have gotten the headlines we needed, and the stock would have moved higher.
Well, at least we know PARS is still a jem, and now more than ever. We know, HU211 is on track and has good chances of getting FDA approval 2 years down the line. We didn't know this a week ago, and yet we can still buy the stock at $1 1/2. Unbelievable !!!
Omer |
