Strange you pose these questions when you must know what you have written IMO is clearly wrong and misleading. I have put your "statements in red to address each one.
I assume you have contacted SPL managment and investor relations and received a response?
Why hasn't the TGA approved Viraleze in Australia yet!!!
Until recently they had not been asked to IMO! WOW IMO they have only recently had a lodgement in the correct catagory as now agreed with TGA. The news articles expressed an opinion that SPL had previously many many months ago been requested to lodge as a medicine ( assumably after lodging as a device but was this not discovered at prelodgement meetings?) but only recently has been allowed to lodge as a device. We have no idea of meeting schedules We have no idea if packaged lodged was complete We have no idea if TGA was "wrong" or has made a exception or given advice to enable SPL to lodge as a device .
Viraleze acts as a preventative against flu Actually IMO all Viraleze has done is in a lab test tube has been shown in isolation to kill Flu. Not IMO quite the same as your statement.
Viraleze acts as a preventative against covid-19
Actually IMO Viraleze has had no human trials and no data in regard to acting as a preventative. It has had a human safety trial only . I believe it probably does but there is no data . The company suggests it can help when used in combination with masks handwashing etc. Unless we see teh new advertising and promotion in UK makeing other claims?
Viraleze has been accepted as a medical device by the TGA
Actually again IMO that is not the full truth . Beware IMO this is a double edged sword as it may limit claims and promotiosn avaliable to SPL to use. The pro is that they may need a lower level of data and lower qualityity / quantity of trials etc. TGA IMO has allowed SPL to lodge Viraleze application as a medical device catagory but there is a lot of assumptions about what was to be in the lodgement package to jump the hurdles required etc etc.Until I see it in black and white IMO there is always a chance that they may be forced to lodge as a medicine if package when fully assessed doesn't back up teh reason for SPL product recatagorisation. . So after a long period of having an " application in with teh TGA and then from a media article ( assuming it is correct) the public and shareholders discover that SPL had been informed that they needed to lodge as a medicine
The active ingredient of viraleze (astodrimer sodium) is used in Starpharma's Fleurstat (as a preventative against bacterial vaginosis. It is used against recurrent bacterial vaginosisThe active ingredient is also used in vivagel condoms
Yes there is a process for using same drugs for different applications .
WHAT IS YOUR AGENDA TGA
Doing their job and following their process? What is SPL agenda and the way it communicates with shareholders?Why would TGA have looked into SPL lodgement previously when they had ( according to articles) informed SPL it was in wrong catagory and ha dnot received any further notification?
WHY HAVE YOU NOT APPROVED VIRALEZE IN AUSTRALIA YET
Ahhh -Only recently lodged , there is a process. IMO medicines and devices have a different process and different teams etc. Why not ask SPL for a timeframe ( said with tounge firmly in cheek) ? Was teh application complete? Has a commitee been set up for this approval and have they had meetings?
Why haven't SPL communicated with shareholdes if they have an idea of possible timelines or any updates in regards to their communications with TGA?
SPL Price at posting:
66.8¢ Sentiment: None Disclosure: Not Held
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