Comet-2 started half year ahead of comet-1. In non-English speaking countries, there were no holding 2 for 1. Even in English speaking countries, the trial sites are not the same. So we can assume there were some comet-1 enrollments. Now with all patients pushed to comet-2, we may have full enrollment in a month(2 months after comet-1 full enrollment) or so if 100 enrollments/month work the same magic.
The interesting thing is that nobody is talking about EXAM. It's been postponed from march to 4th q of 2013 and then 2014. If the trend of 42% to 75% of events continues, we will have bigger and bigger ratio of survival patients between on-drug/placebo . So the longer we wait, the more favorable OS will be. Seems nobody cares, but it's really good sign for other indications.
Yeah, my feeling was that if they double the size of trust-2 existing result, p will be less than or close to 0.05. We will see. They have to combine both trials data. They should spend one more million bucks on biomarkers. Too overconfident.
MS readout should be very soon. HINT-2 announced finish of enrollment on January, and it's a 10-month(?) trial and therefore expected to read on October.
For MS, we have the same issue: which group is good for TSO trial. The discrepancy between Denmark and HINT-1/2 may give us some hints.
With uncontrolled usage of immuno-suppressant, the significance study may be of no value. Without the strict control group and lack of data on the combinational effects of TSO and all available immune suppressing drugs, it's very hard to tell the difference TSO made. This is a very bad trial design. A half-year 200-patients trial without other drugs' interaction may be much better to tell the story -- CDAI 290 or not may not be such a big deal.
Yes, that's my feeling too.
One frustrating thing is we didn't measure the biomarkers for individuals so we lost some precious info about which subgroup responded, which group not and which group reponded to placebo too much.
gosh, it really hurts today. Still holding, the scientists really have to redesign the trial. How can those previous research result don't hold?
I don't know who mikey is. Is this post his?
I'm comically amazed at the responses and comments about CNDO on SA, YMB, MF, etc.
Seems the longs don't even understand basic healthcare. Saw one author refute a claim that the worms could be 'infectious' to others living in the same house, if you aren't careful when taking your spoonful and you spill it. Ummm.., yes a larvae sitting on a counter can then be ingested by someone else. Cripes don't go to their house for dinner, they probably toss the salad on the same counter they prepped the raw chicken on without washing it first. LOL
That's just one example. The longs in CNDO seem to be the most uneducated bunch I've run across. Not saying those worms won't get to market BUT I am saying I won't go near anyone taking them. They won't just have worm larvae all over the place, their natural intestinal flora will be disrupted and they'll have other infections.
I should say you might want to consider change a leader to follow. He might not be as knowledgeable as you think.
I would expect data collecting is much faster than other trials. The results are snapshots of status of patients. For example, the snapshot can be MRI images. It takes precious resouce to take. After taken, you can wait for radiologists to analyze them. Or wait for oncologists to do biopsy. CDAI, on the other hand, are mostly counted by patients themselves for their daily activities, you can't wait, and you don't need experts to follow them to restrooms. After taken, all results are just there. Maybe later, we want to do some endoscopic and radiological analysis. It will cost us more time and money. But not for this current trial.
No doubt a biotech with pending results will attract a lot traders. Just wondering why in you traders' eyes CNDO can't reach $4B IF all trial results come out perfectly in next 5 months? IMHO, in 5 yrs, $50B is not so hard to reach.
NIH is sleeping now. No experiment allowed, no email allowed, mouse-feeding only. Has our NIH-sponsored UC trial started yet? What a government running show!