VIRALEZE™ nasal spray approved in Europe and India by regulatory bodies for sale including 70 countries globally
Launched in how many? Stopped for sale in how many?
Half of Australia in lockdown
Coivd-19 being caught by those fully vaccinated and using masks
And yet
TGA has not allowed it to be authorised for sale in our own company's jurisdiction Australia
We are not sure SPL has even put in a application as wording on announcements is not clear. Have they provided all documentation to TGA or just to consultant and ha sit been lodged. Are they having to change packaging? TGA has fined SPL $93,000 for not complying with rules relating to promoting noon approved products.. SPL has SPL manageemnt have given no updates in regards to UK or TGA so no-one knows what progress or direction thay are taking.
Not sure any blame can be on the TGA following it's legislation and process. I find it hard to believe teh TGA fine came out of the blue and if so have they paid it or are they challening it?
TGA being strict on anything COVID related ( even blind deaf Freddy knew that IMO) - that is their job to prevent bogus things making bogus claims or not following process. SPL job is to comply and lodge all correct documents for approval and comply with approval once / if received and then sell product appropriately. SPL is a large listed company and shoudl have all teh resources to achieve compliance and lodge product documentation and either have internal or external advisors who should stop them falling foul of teh law.
As for TGA should be doing stuff - I can't imagine with correct comprehensive docs to standard required they would stop anything and I am sure tehy would expediate anything urgently relating to covid.
I don't believe in TGA conspiracys but be sure and get em dragged up befpre a senate committee as that would be only waya straight answeror other info may be discovered unless SPL go the legal route or SPL are forthcoming with detailed updates ( unlikely)
Just all IMO. None of us know due to silence from SPL. Market is showing by share price decline they are not comfortable IMO ?
I hope SPL can progress and some positive and timely information soo turns up . Unless some data comes out IMO there is a lot of brand damage done by TGA fine and removal from shelves in UK. Other side is if they drop viraleze and just get on with dep is that a lesser downside as that is why most shareholder are here but again some transparancy openess and information of exactly where that is up to is required ,
