I decided to dig a little deeper here...it looks like they got into a little trouble with this one. Here's a press release that I found on there site...I think it was dated in early 01...maybe 00.
ADCON® STATUS
The Food and Drug Administration (“FDA”) has recently identified the key steps necessary to reintroduce ADCON®-L in the U.S. markets and ongoing regulatory matters related to the Company’s Application Integrity Policy (“AIP”) status. The FDA has recently indicated to Gliatech that it may resume marketing of ADCON®-L in the U.S. provided the following conditions are met: Gliatech submits an acceptable Corrective Action Plan (“the Manufacturing CAP”) for the manufacturing changes arising out of the recall of ADCON®-L in January 2001; the independent re-evaluation of the magnetic resonance imaging (“MRI”) data from the U.S. clinical study demonstrates ADCON®-L to be effective; and an inspection by the FDA verifies the implementation of the Manufacturing CAP.
Gliatech is currently preparing the Manufacturing CAP for submission to the FDA in September 2001. The independent neuroradiologists have each independently read the MRIs and the data analysis process has begun by our independent clinical research organization. This MRI re-evaluation is expected to be provided to FDA and to us by the clinical research organization by approximately the end of September 2001.
Separate from the steps related to the reintroduction of ADCON®-L in the U.S., in July 2001, an 847 patient multi-center retrospective evaluation of ADCON®-L for inhibition of post-operative peridural fibrosis following spinal root decompression was completed on our behalf by an independent third party research organization. The Company believes that the preliminary results from this evaluation indicate that the incidence rates of adverse events in this study were generally consistent with those seen in the ADCON®-L treated and the control group patient populations of our previous clinical trials for ADCON®-L.
Gliatech is also working to resolve its AIP status. Gliatech believes that key elements of resolution of the Company’s AIP status involve ongoing audits by Health Policy Associates (“HPA”), our independent auditor under AIP, and the Company’s development and implementation of an AIP Corrective Action Plan (“the AIP CAP”), which establishes policies and procedures with respect to Gliatech’s data integrity compliance activities.
Discussions with HPA and FDA during the AIP process have also identified the following regulatory items of note:
HPA has issued a preliminary report that indicated that, in HPA’s opinion, Gliatech failed to properly file Medical Device Reports (“MDRs”) during the period of 1998 through part of 2000, but found that the Company improved its systems and procedures with respect to MDR reporting and filed MDRs appropriately during 2001. HPA has conducted audits of selected sites in the U.S. clinical study of ADCON®-L and FDA has conducted inspections and issued inspectional observations and warning letters to some of the clinical sites. In connection with the MRI re-evaluation, FDA has requested that we use a more rigorous two-tailed statistical analysis, which is consistent with FDA’s current statistical methodology, rather than the one-tailed analysis used in the original U.S. ADCON®-L clinical study. In addition, FDA requested that two independent neuroradiologists evaluate the MRIs. ADCON® Solution is currently affected by the Company’s AIP status. Consistent with discussions with FDA regarding the MRI re-evaluation statistical methods, we intend to modify the protocol of the study and file an amendment to use a two-tailed statistical analysis. Such modification will increase the total number of patients in the study, however Gliatech will not be able to submit an amendment until its AIP status has been resolved.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON®-L and ADCON®-T/N and ADCON® Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech’s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of Gliatech’s products, the uncertainty of the success of certain clinical trials, the ability of Gliatech to obtain an adequate supply of the materials used in the manufacture of its ADCON® products, uncertainty of the success of the relaunch of ADCON®-L outside the U.S., uncertainty relating to the Company’s ability to resume commercial distribution of ADCON®-L in the U.S., uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON®-L, uncertainty relating to the re-evaluation of the MRI data from the U.S. clinical study of ADCON®-L, product recalls and the inspectional observations by the FDA, risks relating to legal proceedings, including the outcome of pending litigation and investigations, the uncertainty of market conditions and other risk factors detailed in Gliatech’s SEC filings.
--- Chrissy492@aol.com wrote:
> Hi there,
> My friend had sent this email address to me and I
> was wondering if anyone has
> seen or heard of this?
> http://www.gliatech.com/pages/products/adcon-p.html
> (please just copy and
> paste to your browser, sorry - I couldn't figure out
> how to put it in so you
> could just click and go directly to the web site)
> Love and hugs,
> ~Chrissie xo's
>
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