Keeping tab of supposed FDA process: Here's the latest recap of the so-called FDA process and compare it to the PRs on yonder. Poses a problem for the longs (hey thats old information) and yet it your very own PRs.
On June 9, 2005:
Article for Medical Svcs Intl Inc (OTHER OTC:MSITF) 1:46 PM
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Medical Services to Begin Testing in the United States
THURSDAY, JUNE 09, 2005 1:46 PM
- PR Newswire
MSITF
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EDMONTON, Alberta, June 9, 2005 /PRNewswire-FirstCall via COMTEX/ -- Medical Services International Inc. (MSITF) wishes to announce that it will begin testing of both its VScan Hepatitis C and Tuberculosis (TB) rapid test kits in the United States. Independent testing of the VScan test kits for Hepatitis C and Tuberculosis (TB) has gone very well internationally. Both kits are currently being used for screening in China and the Caribbean.
Completion of the testing in the United States will be further validation of the accuracy of the VScan rapid test kits for Hepatitis C and Tuberculosis (TB). Market studies in the United States indicate that there is a significant demand for an accurate test kit for Hepatitis C and Tuberculosis. With this in mind, the Company will file for regulatory approval in the United States once the testing is completed.
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AND NOW A RECAP OF THE SO-CALLED US FDA PROCESS...NOTICE THE SUBLIMINAL LANGUAGE:
October 23, 2003
EDMONTON, Alberta, October 23, 2003 -- On July 1st, 2003, Medical Services International Inc. (Pinksheets: MSITF) announced that the Company was initiating the process with the appropriate regulatory agencies regarding the introduction and licensing of the Company's lead product the VScan HIV 1&2 Rapid Test Kit in the United States.
Today Medical Services is pleased to announce that it is accelerating its efforts to gain FDA approval of the VScan HIV Rapid Test Kit The Company has agreed to testing procedures and protocols and is immediately shipping samples for independent testing.
This independent testing is being done in the United States and is the next important step in the regulatory approval process for the VScan Rapid Test Kits in the United States. As each step is completed, the Company will immediately move to the next step in the process required for full regulatory approval in the United States.
October 30, 2003
EDMONTON, Alberta, October 30, 2003 -- Medical Services International Inc. is pleased to announce that the Company has agreed to begin live testing of its VScan HIV 1&2 rapid test kit in Florida.
The live testing component will be important in the approval process being undertaken in the United States. This testing also shows the confidence that the Company has in the accuracy and ease of use of its HIV 1 & 2 test kit. The results obtained will be used as part of the data that is being accumulated through independent testing necessary for approval of the test kit in the United States.
October 28, 2003
EDMONTON, Alberta, October 28, 2003 -- Medical Services International Inc. is pleased to announce that it has completed all the necessary testing required for the country of Belize and now has the ability to ship the VScan test kits to Belize.
These results were obtained through independent testing in a US Laboratory. The test results show that the VScan test kits achieved 100% Specificity and 100% sensitivity against the Western Blot methodology which is the gold standard for HIV testing. The Company anticipates that it will begin shipping kits within 30 days. The results obtained in the Belize testing further validates the Company's decision to accelerate the approval process in the United States
November 5, 2003
EDMONTON, Alberta, November 5, 2003 -- Medical Services International Inc. continues to increase its independent testing of its VScan HIV 1& 2 test kit using FDA approved laboratories in the United States. The Company is shipping an additional 1000 HIV test kits to an independent FDA approved facility in the United States for additional independent testing.
November 7, 2003
EDMONTON, Alberta, November 7, 2003 -- On October 30, 2003 Medical Services International Inc. announced that the Company had agreed to begin live testing in south Florida in conjunction with the Company's accelerated efforts to gain regulatory approval for the VScan rapid HIV 1&2 test kit in the United States.
Today the Company is pleased to announce that the Independent Investigational Review Board (IRB) has unanimously approved all aspects of the research protocol and that the testing will start immediately in medical clinics in south Florida and will be supervised by physicians. The Independent Investigational Review Board is an institutional review committee structured in compliance with the regulations of the U.S. Food and Drug Administration (FDA).
November 20, 2003
EDMONTON, Canada, November 20, 2003 -- Medical Services International Inc. is pleased to announce that the final set of testing of its VScan HIV 1&2 rapid test Kit has started and that the preliminary results meet the Company's expectations.
It was previously announced that the first set of live testing in medical clinics in Florida had been completed with 100% accuracy. These results will be used in all filings with regulatory agencies in the United States. The live testing was based on a statistically significant and meaningful sample size and showed that the VScan HIV 1&2 Rapid test kit had 100% Sensitivity and 100% Specificity. Sensitivity is the repetition of a positive result in individuals with the disease being tested for and Specificity indicates that the individual does not have the disease.
The live testing was carried out in conjunction with the research protocol that was unanimously approved by the Independent Investigational Review Board (IRB). The IRB is an institutional review committee structured in compliance with the regulations of the U.S. Food and Drug Administration (FDA). The live testing and the results achieved are of prime importance to the Company's efforts to seek regulatory approval for the VScan HIV 1&2 rapid test kit in the United States.
December 29, 2003
EDMONTON, Canada, December 29, 2003 -- Medical Services International Inc. is pleased to that it has entered the final phase of testing required to submit its application for approval of the VScan HIV 1&2 rapid test kit. The company anticipates completing the final phase of testing by the end of January.
January 14, 2004
EDMONTON, Canada, January 14, 2004 -- Medical Services International Inc. is pleased to announce that the preliminary testing of its VScan Hepatitis B rapid test kit had an accuracy of 100% in under 20 minutes. Standard testing for Hepatitis B requires a laboratory with specialized equipment and the testing takes up to 6 hours to complete at a cost of approximately $75.00US. The VScan Hepatitis B test kit eliminates the need for specialized medical equipment and reduces the cost substantially. Based on the results achieved, the Company has begun preparing for testing of its Hepatitis B test kit in the United States.
January 26, 2004
EDMONTON, Canada, January 26, 2004 -- Medical Services International Inc. is pleased to announce that it has completed further "live" testing of the VScan HIV1&2 rapid test kit in Florida under its IRB procedures and protocols. The tests were performed in medical clinics. The results of the tests showed that the VScan test kits were 100% accurate. The kits were found to be easy to use.
Based on the test results obtained in the United States, Canada, Mainland China and other countries where testing has been completed Medical Services has contacted a US consulting firm that specializes in the filing of the necessary documents related the approval process of its VScan HIV1&2 rapid test kit in the United States
March 23, 2004
EDMONTON, Canada, March 23, 2004 -- Medical Services International Inc. is pleased to announce that it has received the results of its third "live" testing program in Florida. The results of this current test show that the VScan HIV test kits were 100% accurate. The data being collected from the live testing programs in Florida will be part of the data and report being prepared related to regulatory approval in the United States.
April 1, 2004
EDMONTON, Canada, April 1, 2004 -- Medical Services International Inc. is pleased to announce that its participation in the 16th National HIV/AIDS update conference held by the American Foundation for AIDS Research (amfAR) in Miami, Florida was very successful. This was the first opportunity that the Company had to showcase its products to healthcare workers in the United States. The response to the VScan test kits was significant, particularly when the Delegates to the conference realized that the VScan HIV test kit is the only test kit available that picks up an early detector (IgM) for HIV. Other kits currently available only detect HIV at the IgG level which is significantly later than the IgM level. Early detection of HIV is the cornerstone to dealing with HIV.
April 14, 2004
EDMONTON, Canada, April 14, 2004 -- Medical Services International Inc. is pleased to announce that that it has completed a major test of its HIV 1&2 test kits in the United States. The samples used in the test were obtained geographically from all over the United States. The independent testing was done by an FDA approved U.S. laboratory.
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