Perhaps Oz was a plan B when SAR lodged their application with MHRA ... The fact that we already had an organisation registered in Oz in time for the application there would suggest this ... Our management haven't been sitting on their derrieres all this time as some would suggest ... LH&K Mafuta
From what Tim says it looks like the studies (Note plural) will stay in Oz:
"We have identified Australia as the ideal location for these studies for a number of reasons, including its thriving research and development ecosystem, diverse patient population, internationally recognised regulatory authorities and supportive R&D tax credits system. We are confident that Australia's regulatory process will enable us to move forward efficiently and effectively."
"See" you at the meeting. LH&K Mafuta
https://twitter.com/Edison_Inv_Res/status/1636684048247521280?t=6Wd5OAbbZTH_ryg_S84J5g&s=19
This post is not aimed at any individual it is just a general observation. One of the biggest problems of most chat rooms is the anonymity if affords posters. I would hazard a guess that at best only one or two on this board know each other. For example, how do you perceive me? Am I male, female or any of the multitude of gender identities that are in existence. Am I young middle aged or old. Am I British or from another nation? Do I have multiple accounts and able to post as more than one person? What is my real intent …. Despite what I may portray in my posts … the sad fact is chat rooms are being used to groom children, scam pensioners, and promote scam romances. Cybercrime and online bullying are rife too … what’s my point? … unless you know the person who is posting personally you must take every post with a requisite amount of caution. Share chat rooms are mot immune … We have some valuable information posted in this chat room, but no one should be buying or selling based on the opinions or information offered here, you must DYOR … That having been said I do miss the posts from the persons behind the aliases Thoth and Working in Pharma. LH&K Mafuta (and that’s not my real name)
Potty sorry about your father-in-law. :0(
If indeed the Edison report is accurate regarding the status of the CTA as being "rejected" then our BOD are out of line and are witholding price sensitive information. The NOMAD would also be in hot water. I know which report I think is more accurate, however the term "rejected" is indeeed open to interpretation.
Whatever the case we now need to look to Australia and see what develops there. I am confident that we won't have long to wait.
Best regards to you and yours.
Mafuta
That the more some post the more stupidity they reveal ... Dennis Thatcher once said: "It's better to keep your mouth shut and be thought a fool than to open your mouth and remove all doubt" ... I wish some would follow that advice ... Ho hum
Not the way I read it. CTA decision is on hold pending input from a 3rd party is how I read it. If the CTA had been rejected that would have to be clearly stated in an RNS and that is a legal requirement. The BOD wouldn't dare do otherwise. Or does someone here know more than the BOD does? Now that would be insider trading and equally illegal. Or perhaps years of experience of drafting compliance documents and procedures have all been wasted on me. I know who I would prefer to believe other than some faceless posters on a BB with ulterior motives. LH&K Mafuta
Silver
They are different routes to the same goal. They both end up in a clinical trial. The CTN route can be used where there is adequate preclinical information available. The CTA route is for higher risk or novel trials.
You can read all the blurb here:
https://www.tga.gov.au/resources/which-clinical-trial-scheme-should-i-choose
LH&K
Mafuta
I found it interesting that SAR has gone for a CTN and not a CTA. Here is what I found on the regulator's website:
"The CTN scheme may be used for earlier phase studies if there is adequate preclinical information available, especially regarding safety. The CTA route is generally for high risk or novel treatments, such as gene therapy, where there is no or limited knowledge of safety."
It would appear then that the BOD is confident of the preclinical evidence they have so far to satisfy the CTN route ... Importantly the CTN is a much faster route.
LH&K Mafuta