Response to Neurochem (NRMX) Inquiry
The problems with the data relate to how the statistics are compiled, analyzed and presented to the FDA. The company has locked the database -- meaning no more data will be collected to support the analysis -- and the company has also received permission from the FDA to modify and add to the agreed upon methodology for evaluating the data. And there could be problems --patients were on other medications, different trial sites may have, managed the patients and the collection of data in different ways, and the patient population may have too many variations to begin with to ensure accurate results.
Statistical variations and some fiddling is normal -- the question is how much fiddling and whether the company needs to do an unapproved (by the FDA) analysis to prove the drug works., This is doubly true for a drug that will be taken for a long time and is for symptomatic relief, not a cure.
I know this sounds like double talk but the data is not "out there" yet. But this kind of confusion could be a prelude to regulatory problems or an outright rejection of the application in the form of an approvable letter -- this kind of letter says we might approve it, do another trial or re-cut the data.
Comments (3)
The good doctor at Neurochem is stalling. I smell fear, doubt, uncertainty and flat out failure of Alzhemed.
I was in New Orleans last week and at the airport I saw a T-shirt saying the following:
"When all else fails, manipulate the data".
I should have bought one and sent in Laval. I'm sure these boys up there are trying hard to find the smallest shread of evidence showing drug efficacy.
By now, I figured they've analyzed groups, subgroups, subgroups of subgroups, and subgroups of subgroups of subgroups...and then just before they gave up they thought "we better to a PIPE".
Posted by Jw | May 9, 2007 8:30 PM
Posted on May 9, 2007 20:30
Hi Michael,
In the past you've been very helpful in deciphering how the FDA may respond to various submissions of data and how they are most likely to rule. I am hoping that you can provide some thoughts on the Neurochem (NRMX) Alzhemed Phase III trial data issue.
I've pasted a 6/13 Motley Fool article on Neurochem (NRMX) below FYI (it certainly does not need to be reposted). A Thankful Subscriber, Bill Poppe
Neurochem Collects the Data
By Brian Lawler June 13, 2007
11 Recommendations
Earlier this week, drug developer Neurochem (Nasdaq: NRMX) released some more hints as to what sort of data investors could expect from the company's just-finished phase 3 study for its potential Alzheimer's treatment, Alzhemed.
In April, Neurochem announced that it would take another couple of weeks for the data from its Alzhemed clinical trial to be finalized, since the company needed to find "an accurate statistical model that appropriately describes the data and provides accurate results."
At an Alzheimer's disease medical conference this week, the lead author for the drug's phase 3 trial added that the data produced in the 1,052-person study varied significantly and unexpectedly between the study's different testing centers. This was cited as the cause for the delay in releasing the clinical trial results.
Neurochem also announced in a press release that preliminary data showed Alzhemed faring positively on the study's primary endpoints, which are cognitive tests and an MRI scan. This sounds highly positive for Alzhemed. However, before investors get their hopes up for the results, they should consider that Neurochem also states that it can't ascribe any sort of weight to this preliminary data because of the continued revision of the study's statistical model.
The FDA doesn't like data that is hard to interpret, nor is it a fan of retrospective analyses. In Neurochem's favor, the FDA knows that it is extremely difficult and complex to run a clinical trial in Alzheimer's disease. It also knows that there are few treatment options out there for the estimated 27 million sufferers worldwide. Nonetheless, with so little clinical data released on the use of Alzhemed in humans, not to mention the data-juggling Neurochem is doing, investors are gambling on a drug that is likely to produce controversial study results.
Posted by Bill Poppe | June 18, 2007 5:05 AM
Posted on June 18, 2007 05:05
Michael,
A quick follow-on comment to my last recent one on NRMX: I am realizing now that NRMX's KIACTA PDUFA date is July 16. It doesn't appear that they have provided any additional clinical data to the FDA as of yet. It appears that NRMX's attention may be divided between sorting out the Alzhemed clinical data and providing additional clinical KIACTA data. What is the likelihood of success in either endeavor? Thanks again, Bill Poppe
Posted by Bill Poppe | June 18, 2007 6:19 AM
Posted on June 18, 2007 06:19