The "white matter damage" statement by Perrin is well documented on the Facebook Invivo Investors board. IR even responded to an inquiry about it, replying that this exclusion would only affect 10% of the patient pool. Whether that statement refers to zero damage or some degree of damage was not clear and is irrelevant. The fact that Invivo could be cherry-picking patients explains the FDA wanting a control arm all of a sudden. If you have a better explanation I'd love to hear it.
Assuming this kind of control arm is required it could be done as a mod to the existing trial. It would need to be SCI patients meeting identical selection criteria. It would need to be future patients since they need to be evaluated the same way as the current patients and because you don't want to bias the control by consciously or unconsciously selecting patients based on already known outcomes. The control should be larger than 20 patients to be more statistically meaningful since comparing two small samples to each other would produce dubious results. Negotiations and the the new design approval process would eat up several months but the current enrollment should be able to continue during that time. Larger trial will increase costs and probably extend completion into 2018.
Yes, they would have had to update the exclusion criteria, but they didn't which is why I suspect that is the issue with the FDA and the control arm. It was before patient 5 converted. It wasn't put out in a PR. It was something MP said (I think it was an investors conference) back around January. It was well documented on the Invivo Investors Facebook site. One of the posters there even contacted IR about it and was told it would only restrict the patient pool by about 10%.
That kind of injury would have white matter damage but so can contusions. The former is specifically excluded by the study eligibility criteria the latter is not. In January, Perrin said because patient 2 and 5 had secondary injuries involving white matter damage they would no longer be including patients with secondary white matter damage.
The OPC was based on a historical control which had an expected spontaneous conversion rate of 16%. So apparently the historical control is no longer sufficient. Additionally, I doubt they would use the terminology "control arm" if they really meant historical control. Most likely the historical data does not have the fidelity necessary to duplicate MP's cherry-picking of patients, e.g. excluding white matter damage. MP had a sure thing and then he got greedy and put his finger on the scale and the FDA isn't happy.
A control arm that selects patients who failed the eligibility requirements would be useless as a control arm. The control arm needs to "control" factors other than the course of treatment.
Not how it works. The conversion rate doesn't automatically go down when you enroll a new patient. Only patients that have converted or who have reached 6-months get counted.
"lots of patients", seriously? Canada has much smaller population than the US but spread out over as large an area. You can expect about 20% of the SCI injuries as the US and with one hospital in Toronto the vast majority of that 20% won't be able to participate. If US enrollment rate is any guide you will be lucky to get 1 patient a year out of Toronto.
If you were ever looking increase your position wait a couple weeks when we're trading in the 4's. The control arm is going to kill this stock and possibly the trial unless it gets cleared up. Anything other than a status quo resolution is going to add cost and time to the trial.
I have no idea why they would feel the need to cherry pick either. MP decided to #$%$ defeat from the jaws of victory. Do you recall when they said they were no longer going to accept patients with white matter damage? That is an example of cherry picking. Exclusion criteria doesn't say anything about white matter.
over 2 patients a month? Right ...
I think they hired a bunch of geriatric COBOL programmers and said make YMB look like Twitter
Not sure how long this will work but use this link to get to the old format. http://finance.yahoo.com/mb/aal/?bypass=true
T3 is explicitly in the inclusion criteria. But their previous statement that they would start excluding patients with white matter damage is not part of the exclusion criteria. That is "Cherry Picking". Have to wonder what other unofficial exclusionary criteria they have implemented.
Probably because FDA thinks they are cherry-picking the patients thus invalidating the current historical control