NIOSH approvalAnyone knows when this is expected?
At the AGM, they said they were in the process of getting this approbation & it should be quick (matter of weeks/couple of months max).
I don't have any insider info, but this approvaled seemed to be related to something else (contract?) because they canceled the FDA just for it. (and also because the original FDA approval was not covering anti-viral claims...).
Anyways, they said that they will re-apply for the FDA after they have NIOSH, so... everything seems to start moving as soon as they have this first step done.
Thanks for any info...
FYI, here's the press release with related information...
MONTREAL,
Nov. 6 /CNW Telbec/ - Noveko International Inc. ("the Company") announces that it is refocusing its strategy for the marketing of its Noveko(TM)masks and respirators in
North America. In this regard, the initial 510(k) submission for the Noveko(TM) 3xEZ antibacterial surgical mask to the US Food and Drug Administration ("the FDA") ("the initial FDA submission") has been withdrawn. The prevailing A (H1N1) influenza virus pandemic context and the time and cost imperatives associated with the initial FDA submission process - which took longer and proved more complex than initially expected, moreover being limited to the Noveko(TM) 3xEZ surgical mask which had only an antibacterial claim - led the Company's management to refocus its strategy to prioritize the accelerated marketing of its Noveko(TM) masks and respirators in the
United States, outside healthcare institutions, as well as in
North America, globally.
The Company will submit to the National Institute for Occupational Safety and Health ("NIOSH") an application for the certifications (N95, N99) still generally used in the North American market, for its Noveko(TM) masks and respirators, which it could not do while the initial FDA submission was underway. "We believe that the North American population would benefit from having faster access, as is the case in many other markets worldwide, to our antimicrobial masks and respirators, which have been tested and proven effective not only in filtering out, but also in neutralizing a broad spectrum of viruses and bacteria. Even though Noveko(TM) masks integrate antimicrobial ingredients, some markets still seek NIOSH recognition when making their purchasing decisions, although NIOSH standards are only particle filtration standards," indicated Barry McDonald, Chief Technical Officer of the Company. Noveko Inc. ("Noveko") also plans to submit the mask product labelling to the US Environmental Protection Agency ("the EPA") for certification for industrial use, as the antimicrobial chemical additive incorporated into Noveko(TM) masks and respirators is already EPA registered under the US Federal Insecticide, Fungicide and Rodenticide ("FIFRA") Program.
The Company's refocused strategy will simultaneously concentrate on developing the test protocols and obtaining the required performance data to support a new 510(k) application to market its Noveko(TM) masks and respirators with an antiviral claim for healthcare institutions in the United States. As previously announced by the Company on September 11, 2009, at a formal pre-IDE (investigational device exemption) meeting with the FDA, the parties held discussions with respect to an additional claim that would allow Noveko(TM) masks and respirators to be marketed as a medical device reducing the exposure to airborne influenza particles. The FDA has indicated that it would treat any file supporting such an antiviral claim in priority. Furthermore, a new submission by Noveko would allow the Company to include all the improvements currently developed in the design and antimicrobial properties of the Noveko(TM) masks and respirators since the filing of the initial FDA submission.
"We are confident that the experience acquired throughout the initial FDA submission process will be highly useful for a new 510(k) application to gain FDA clearance for our masks and respirators with an antiviral claim. Furthermore, a new submission will be supported by an enhanced product performance overall. Finally, we do not expect our repositioning strategy to have any negative impact on mask sales worldwide. On the contrary, it will give us easier and faster access to a wider market," added André Leroux, Chairman of the Board and Chief Executive Officer of the Company.