Reposting this connection mentioned in another post.
And Chugai of course!
We just have to wait and see what they/Roche decide.
When you mess with stroke with small numbers usually its a total disaster. What we have here is a miracle if these values can be repeated. They said exploratory, and that's exactly what we got.
There is not going to be an audio link for Glasgow.
Athersys never said there would be.
Chugai will be the decision maker.
The exclusion of tPA+mechanical reperfusion makes sense. This is not Multistem's group.
NIHSS (neurologic deficit) detects benefit the best and will be used in the next trial.
2.) 24-36 hours post-stroke
3.) Exclude tPA + mechanical reperfusion patients
*Increase enrollment to 120 patients in each arm.
If we can confirm a next trial, ATHX is a green light.
Biotech is one of the most self correcting environments out there.
Bubbles are hard to come by with a built in FDA pop'er called clinical trials.
Many, many successes: PCYC, BMRN, etc.
Many, man failuers: DNDN etc.
ATHX is on its way IF Chugai likes the data.
As it turns out, the NIHSS Improvement is the best with 21.1% improvement over placebo. So the NIHSS is best detecting the improvement. Good to know.
Piper Jaffray says Athersys will present Phase II MultiStem data at the European Stroke Organization Conference on Sunday. The study has a high bar for success and is more likely to miss the primary composite endpoint, Piper states. The stock could potentially trade as low 45c, the company's cash position, on such an event, Piper believes. However, if the study shows statistical significance on the primary endpoint, the firm thinks shares will trade "meaningfully higher" as MultiStem would be the first new stroke therapy in 20 years. PIPER SAYS IT WOULD BE A BUYER OF ATHERSYS EVEN IF THE STUDY MISSES THE PRIMARY COMPOSITE ENDPOINT BUT HITS ON SECONDARY ENDPOINT OF NIHSS. The firm keeps an Overweight rating on Athersys with a $4 price target.
Make your way to the lobby for coffee and begals.
Dr. Hess is warming up.
Mmmm Mmmm Mmmm Mmmm Mmmm
Multistemmmmmm 36 hours or less saves lives!
Hess called it, "If MultiStem is safe and there is a signal of efficacy, a late stage phase IIb-III trial is planned."
Int J Stroke. 2014 Apr;9(3):381-6
They informed me that the NASDAQ is not in Japan.
They have not heard of ATHX PPS.
They said they will be the decision makers about what happens with Multistem in their country.
They said say hi to Mr. Gil.
Vv, this is as good as it gets in phase 2 stem cell world.
My opinion is that we have a big winner.
If we get a 10 pps early buyout deal, all your questions go away.
Stroke is a massive burden. Multistem will pay for itself.
It is prudent, and it will save money by enabling stroke vicitms to care for themselves.
Chugai is the decision maker here, not us, and not the market.
The results are mindblowing.
Let go of the media headline and reflect on the actual data.
The scientific method applies both inside and outside the classroom.
For a phase 2, the results are outstanding. We have defined the window, and the benefits are substantial. The benefits more than justify the cost.
Of course we needed more patients, phase 2's always do. I ranted about sample size calculation, but this is the nature of phase 2's.
No path to success is ever smooth. It is always a struggle.
Multistem is on its way...
If you go to ClinicalTrial, you will see the hypothesis clearly stated:
"The hypothesis is that MultiStem will be safe and provide benefit following an ischemic stroke."
Multistem provide benefit following an ischemic stroke if given less than or equal to 36 hours following the stroke.
The media headlined the failed primary endpoint inclusive of the 36h to 48 hour patients.
The media reported success of the 24 to less than or equal to 36 hour patients.
Defining of the success window started sinking in late pre-market and recovery began.
"Cohort 3 will use the highest safe dose, 1:1 randomisation to placebo or MultiStem as single IV infusion 24-48 hrs following ischaemic stroke."
Now we know when it give it...
I think they are setting traps for naysayers to ask these questions, and then explain just how fair they have been. Athersys has bent over backward to make sure the placebo arm of the comparison has every chance to win, and it doesn't.
Multistem is that good. I think we have a winner. Chugai is going to run with this.
This statement applies ONLY to the Multistem arm.
Athersys is eliminating any possible boost from a tPA+mechanical clot removal combo.
They leave this boost in the placebo arm.
Multistem still wins.
* Excludes confounding data from patients that received tPA+mechanical reperfusion+investigational product (Multistem)