Great string of conversation folks, and very compelling. The main problem we all have is that the company gave us very little to go on. "significantly" is a worrisome term and not being able to reconcile the vaiiances within a reasonable timeframe certainly is worrisome as well. There is a reason no one has yet to resolve the testing for appendicitis and I think we are experiencing why. If the markers as has beeen pointed out, are too vast and occur too often away from the target, that explains the vairiances in both trials, but can they be resolved?
Patience is going to be the key here. JMHO but I would think we are going to hear from the company within the next 30-90 days concerning more detail on the results and there plans with the FDA. From a trading perspective, and as has been pointed out already, downside from here is limited and upside favorable but not great yet as we need god news in a situation that leans toward trouble. I give us a 30% chance of hearing some good news out of this trial and about 50% with the rest of the stiry. Not a great place to be but we are here already, might as well stay for the outcome. GL to all has2
I would disagree. You have the three previous trials and the knowledge of the set-up for the 4th. The endpoints, cutoff levels etc. if they were in place in the pivotal trial the study would have been considered a success. Why when this study was prepared by Becker & Assoc. with a lower cutoff, more endpoints etc. would anyone think this test would be that much different?
Wait for the data because I bet it's very good with the exception of a couple hospitals not following protocol. That's my "guess" as to the outcome. With the larger study population, even with the few that may not have followed protocol they will probably still have enough data to file the 510k if they want.
The stocks at $1.40 because the market absolutely HATES uncertainty. I'd be expecting a big rebound upon the release of the data.
The "failed" previous trial had 3 hospitals if I remember correctly. One of the three had poor results which didn't leave enough of the 600 patient trial to submit. This trial was 800 patients and 13 or so hospitals with supposedly better oversight through Becker and Assoc. Also, the rapid reader needed a trial regardless and works easier and perfectly as I understand it. "If" there are too many hospitals who didn't follow protocol (which I doubt) they will quickly begin the rapid reader trial since the devices are already in place and far easier to use. They also have the data from this trial to use in perfecting the rapid reader trial.
There will likely be enough good data from this trial to submit the ELISA for a 510k but even if they decide they're not going to bother with it they know which hospitals to focus on and use for the reader trial. The company will get this device approved one way or another. The amount of data these guys now have is unbelievably massive. Don't think for one second the reader's trial won't be overseen and monitored with a magnifying glass. I bet the vast majority of the data from this trial is very strong with a few hospitals screwing up. In the end it won't matter. The reader will have near perfect data and get approved. The high likelihood alone will boost the stock much higher than todays level. The data in the previous trial wasn't that bad if you remember so I have a very hard time believing the data with the cutoff levels and endpoints adjusted are actually bad.
Good data means the test works. If the test works then the reader will get approved. Another point, the stock probably has 10-20 cents of downside from here with infinite upside with an approved rapid screener.
We sure do. They have a lot riding on this thing. Thing is, they had only 8 hospitals collecting data. Even if 2 hospitals had skewed data points, it takes time to collect everything and explain why.
I have an acronym for you- STFU! Fact- the test flat out does not work. And now bovipure is defunct. What does the company have? Nothing. You pathetic baggies need to consider the sears tower skydeck- as a jumping platform.
No it doesn't. First test showed NPV of 97% with lower cut-off. Data variability can be caused by many factors. If ALL hospitals showed crappy data, there wouldn't be variability. Depends on hospitals and protocols. There were only 8 hospitals used so even if only 2 messed it up, throws the whole data off.
If I had to guess, I would imagine that the variability is due to the fact that MRP 8 and MPR 14 are non-specific inflammatory markers associated with macrophages. MRP 8/14 can be elevated in several different inflammatory conditions, such as rheumatoid arthritis, lupus, type 1 diabetes, cardiovascular diseases, and gastrointestinal diseases.
Given these multiple sources of false elevation, the "variability" in the data might be explained by too many people at one or more sites coming to the ER with belly pain caused by these other inflammatory conditions.