Re: Clarification on latest N/R
in response to
by
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Message: A PM I would like to share...
Question posed by someone at SH to Alda yesterday and subsequent responce
thanks for your question - below is a summary from the President, Terry Owen which hopefully explains your query:
Hi Mr Scott Young
I Have been a shareholder of Alda Pharmaceutical since Nov of 2007.
I will try to make this short. I am just wondering about May 6/08 & October 30/07 press release.
October 30/07 stated "Alda has applied to Health Canada for a DIN# for a new antiseptic skin cleanser"
May 6/08 stated that ALda will approach Health Canada for a CTA for skin antiseptic for surgical use & for personal sanitation.
Please clarify this for me.
Is this the same product?
Is this what was holding up the DIN#?
If not maybe the company could release a tid bit to the shareholders about the DIN# and its progress.
Thank you in advance.
thanks for your question - below is a summary from the President, Terry Owen which hopefully explains your query:
> There are two different approval processes. The DIN we are waiting for is
> for Approval #1 in Canada for consumer use. No human trials or testing are
> required for this DIN to be issued. By taking this route, we can secure a
> quicker approval and make sales of the product with limited claims while the
> human testing is in progress. The approval has taken longer than we were
> originally advised.
>
> The news release today refers to Approval #2 to include surgical use. The
> T36R formulation will go into human trials for Canada and the EU ASAP. With
> successful completion of the human trials, Approval #2 will allow the
> product to marketed for surgical use and will also allow broader claims for
> the product that is being sold to consumers and will allow sales in the EU
> and the US once all of the FDA requirements are met.
>
> In summary, the pending DIN allows faster sales while more extensive testing
> is in progress to allow broader claims.
> for Approval #1 in Canada for consumer use. No human trials or testing are
> required for this DIN to be issued. By taking this route, we can secure a
> quicker approval and make sales of the product with limited claims while the
> human testing is in progress. The approval has taken longer than we were
> originally advised.
>
> The news release today refers to Approval #2 to include surgical use. The
> T36R formulation will go into human trials for Canada and the EU ASAP. With
> successful completion of the human trials, Approval #2 will allow the
> product to marketed for surgical use and will also allow broader claims for
> the product that is being sold to consumers and will allow sales in the EU
> and the US once all of the FDA requirements are met.
>
> In summary, the pending DIN allows faster sales while more extensive testing
> is in progress to allow broader claims.
Scott Young
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