Hi John!
Welcome to thread.
I assume you have better knowledge on stroke and other CNS disorders than I do. I do not have any, only what I can read from books or articles.
What I found is that from 100 scientists you will have 100 presentation how stroke accrue and what is the best way for treatment. One is for real: Calcium ions damage neuron cells and this is related to glutamate concentration increase. Because there are two major type of stroke: "burst" and "clot", any treatment have to take account on this two factors.
There are many ways to interpret "pure" information data in CNSI press release related to phase II. If you check, probably you didn't) previous my posts, I specifically asked all CNSI followers and others for full data regards the phase II. If yours article is commentary not a investigators article, I will not take seriously. I will be glad, if you have additional data, to have look on it, and I will consult somebody who have better knowledge than I have.
For those reason my review have several points:
1. CNSI and BI have much greater expertise on NMDA receptors, brain chemistry, stroke treatment than someone can conclude by simple news. Specially BI, which have his on NMDA receptor antagonist in clinical, and experience for other many failure clinical trials for stroke.
2. BI have analyzed all data from trials, prepare protocol for phase III and submitted application to FDA. If the data in phase II are so "pure" as you analyzed and there are side effects as they announced, there are no slightly chance that FDA will allowed phase III.
3. BI committed itself for large financial expenditure for clin-trials, and their own expertise and experience in stroke treatment suggest that they have good reasons for this step.
4. Phase II data are related to (max dose) 110 micrograms/kg which is for average person (100 kg) 11 mg for full treatment (4 hr). Phase III protocol is 15 mg initial and 3 mg/hr up to three days which is total 230 mg or ~20 times in phase II. How will this be colerated to efficency we will see.
According to yours posts in NTII thread, this patients will sleep for at least three months or will never wake-up(dose adjusted)!
Tried to read sometimes between words, not jump in to conclusion on some data.
Simple, I have a fait in BI and CNSI and their ability. Also, stroke is to complicate to be treated only with NMDA antagonist. Antagonist, Cerestat if approved, will be in combination with other drugs. But, as the first, necessary, and useful therapy for those victim whose life and disability are on line.
BTW, what are the reasons that Mimetidine will be good treatment for stroke?
I think, I have a better way to spend my time. Lot of the core-research to do on biotech companies. Please, spare me further discussion.
To all: It is difficult to follow CNSI after this dive. This is not a "panic drop", and it is good opportunity to add and accumulate. Nobody said that there are no risk. Can we make money if we can't accept risk?
mz |