MedSmart Group Inc (MSGP)

[SPARK]

Great info from Sterling: With SSWC & FDA Approval… The submissions have taken place and more are continuing which leads me to think that a major announcement with a major pharma company is near at hand to be announced.

The key thing was to get their ”medical device” submitted. This is because FDA over the past year or so has a 100% approval rate for all of the 510(k) applications that were submitted. This is why that within the three major meetings that the SSWC CEO had with a major pharmaceutical company had expressed serious interest and indicated that they would sign a 7-figure contract with SSWC to acquire the intellectual property after the FDA filings have been made as PR-ed below on 21 Jun 2010:
ih.advfn.com/p.php?pid=nmona&article=43308830&symbol=SSWC

This is also why it is important to consider what was also stated in the PR above that in June 2009 the company obtained all rights to the GlynnTech, Inc. cancer drug delivery system, at cost which includes one issued patent (US No. 7,637,889 B2), one pending application, three years of development work, a prototype, numerous CAD drawings of various embodiments, risk analysis and development pre-FDA filing history. The submissions have taken place and more are continuing which leads me to think that a major announcement with a major pharma company is near at hand to be announced.



The time frame for SSWC getting FDA approval will not be as long as some might believe simply because what they are submitting for approval will be considered an apparatus/product and not a medicine. FDA approval times for medicines could take years as it goes through its 4-Phase approval process; Phase I = 1 to 3 years; Phase II = normally 2 years; Phase III = 3 to 4 years; Phase IV = an ongoing evaluation after the FDA approval. One could confirm these times by looking through some research provided in the link below:
http://www.fool.com/specials/2000/sp000405fda.htm

The official term used for an apparatus/product is actually called a ”medical device” for researching through the Food Drug & Administration (FDA) website. SSWC will have to submit a 510(k) form/application to the FDA panel in order to position themselves for FDA approval for their medical devices. From doing my research, this could normally take 2 to 3 months for the approval of their ”medical device” versus years if it was a medicine that they were submitting to the FDA for approval. I do trust that at least one of their medical devices has already been submitted for approval.

The key thing was to get their ”medical device” submitted. This is because FDA over the past year or so has a 100% approval rate for all of the 510(k) applications that were submitted. This is why that within the three major meetings that the SSWC CEO had with a major pharmaceutical company had expressed serious interest and indicated that they would sign a 7-figure contract with SSWC to acquire the intellectual property after the FDA filings have been made as PR-ed below on 21 Jun 2010:
ih.advfn.com/p.php?pid=nmona&article=43308830&symbol=SSWC

This is also why it is important to consider what was also stated in the PR above that in June 2009 the company obtained all rights to the GlynnTech, Inc. cancer drug delivery system, at cost which includes one issued patent (US No. 7,637,889 B2), one pending application, three years of development work, a prototype, numerous CAD drawings of various embodiments, risk analysis and development pre-FDA filing history. The submissions have taken place and more are continuing which leads me to think that a major announcement with a major pharma company is near at hand to be announced.

This is why it is important to understand the magnitude of the PR below released on 27 July 2010 indicating that… the second biodegradable disposable bandages patent application will be filed August 1st as forecast, and the third application, with co-inventor Dr. Alain Martin (of Listerine and Neosporin fame) is in progress. A fourth application for a burn treatment wrap that favors swelling in only one direction has been initialed. This product would provide temporary artificial skin to burn victims, without the problematic three dimensional swelling that has previously occurred with absorbent burn wound dressings:
http://ih.advfn.com/p.php?pid=nmona&article=43759491&symbol=SSWC

To have one of your products submitted for FDA approval with the doctor who is the founder of Listerine and Neosporin should be given huge attention for where this is going in my opinion.
A while back I had gotten through to speak to some of the FDA officials over the phone. Here’s what I was told in general as I will reference it to SSWC which could be verified from the link below under the section towards the end titled 510(k) Status Program:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm

FDA approval for a device usually takes less than 90 days providing everything is properly done. Since SSWC has already submitted their 510(k) application for their first application, approval could come any day for this first application. As I have stated before, there is a 100% success ratio from simply just getting your 501(k) properly submitted to where it’s not rejected.

Under the 510(k) Status Program, SSWC is only required to request for an update of the status of their 510(k) application 90 days after their initial log-in. Any time before 90 days, they have to wait until they are told of being granted approval or request for an update after such time. SSWC can only request status reports every 30 days following the initial status request. SSWC will obtain a status report by filling out the status request form, FDA 354114, and fax it to the CDRH office identified on the form. Then within three working days after a status request is received, CDRH will send SSWC a fax that includes the last action taken on their submission and all other pertinent information.

I think it was very important that the company informed us shareholders of where they are with their submission processes. Their 510(k) application for FDA approval is almost a given in my opinion as the levels of scrutiny are much different than those associated with obtaining FDA approval for medicines as I had mentioned above.

Below we can confirm the date for any tentatively scheduled advisory committee meetings related to SSWC for getting their FDA approval for their medical devices. Click on the link below and scroll down to August 2010:
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm153468.htm

Below is some more information that I believe to be essential for understanding the process of FDA approval for ”medical devices” that could prove helpful:



http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm#link_9
Premarket Notification 510(k) submissions for medical devices are reviewed and processed by the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). The Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) within CDRH are responsible for the processing and review of 510(k)s for marketing clearance in the U.S. Branches within these offices are organized according to medical scientific disciplines.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134573.htm
There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.

Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls.

The "Special 510(k): Device Modification" utilizes the design control requirement of the Quality System Regulation (21 CFR 820) and may be submitted for a modification to a device that has been cleared under the 510(k) process. The Special 510(k) allows the manufacturer to declare conformance to design controls without providing the data. While the basic content requirements of the 510(k) (21 CFR 807.87) remain the same, this type of submission should also reference the cleared 510(k) number and contain a "Declaration of Conformity" with design control requirements.

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?IPaddress=&dbname=1998_register&docid=98-2498-filed
…Under section 513 of the act (21 U.S.C. 360c), FDA must classify
devices into one of three regulatory classes: Class I, class II, or
class III. …

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Just based on where SSWC is at within their submission process, it appears that some major things are seriously in works and are close at hand for being complete. This is just from their pending FDA approval medical devices.