What a load of stuff from the kind insto! I have some comments and questions!
CU6 (1) lost the opportunity to demonstrate the science when the (2) FDA disallowed a head to head comparison. (1) How can Cu6 lose an opportunity when Cu6 have more trials running than what the FDA requires from them, and in this case, while adding to them via this head to head? (I will share my views of why some may be concerned about head to heads). (2) How can the FDA "disallow" a trial? The FDA's primary role is to set and advise trialists of the minimum standards required of them to meet the threshold for acceptance, registration, or approval (something like that)! Whatever else you do is your business. So, it does not make any sense to say that the FDA disallowed a head to head. By agreeing (or advising towards) the design of Clarify and Amplify, they clearly indicated to Cu6 that it is not a requirement for approval.
And while a local Australian hospital (with affiliations) is attempting to do a study, this means little internationally.
Respectfully: this is outright false! This (IMO), should completely invalidate this person's argument, and bring to question their position as an advisor of any kind. It is scandalous that they advise instos, or anyone else!
Trials done in Australia and Timbaktu mean a lot internationally. Since we are talking radiopharm in particular - please look at the authorship in Pluvicto studies and see where they are based. You may want to check the Lantheus investment in RAD - esp the second one.
Please do not confuse FDA approval requirements with meaning: its different. Even China and Japan will sometimes/often require additional small trials to be done in their populations as a prerequisite for approval there - thats just a small top up, with the vast majority of data coming from elsewhere.
He believed a local study smelt of desperation by AT.
There are thousands of Investigator Initiated Trials happening on everything including Ga68 and F18 products! Is that a sign of desperation by those doing them? How does more evidence become evidence of desperation?
The view given was that with the long lead time to commercialisation, other products and domination of the industry by BP would neuter the great science.
While the time factor seems sensible, how does delaying revenue fare against the charge of desperation? It does not make sense!
The other point he made was that AT had also hung his hat on a cheaper product and this is also no longer valid. As a believer in the science and a holder I hoped he was wrong. The price was around $7 at the time and falling.
Your guy had a lot to say, it seems! Thanks for sharing! But did this insto adviser share his concerns with his clients?
Is there a report somewhere showing some adjustment to the sp that he believes Cu6 should be at?
IF he did share, and the instos acted accordingly: what a shame! They were told so much hogwash, for a fee! Anyhow, if they exited, they probably feel indebted to the guy, so well, good for them! Fraudsters do win sometimes.
Is there a report somewhere showing some adjustment to the sp that he believes Cu6 should be at?
---- A Brief Comment on Head-to-Head Studies a) Drug developers often avoid head-to-head studies due to the risk of unfavourable outcomes - either failing to demonstrate non-inferiority or failing to achieve superiority. Even when they do them - they may want to avoid superiority as an objective as that can even be harder to prove conclusively (you need a much larger sample size than what is needed in non inferiority). The study at St Vincent's is observational with a sample size of 50 - I don't think that sample size was formally calculated and powered, but it will still bring valuable info. b) However, these head to head studies are valuable in establishing true Best-in-Class status, which aids decision-making and strengthens pricing power. Indirect comparisons are not always reliable on this matter, leading to endless debates. c) Competitors understandably dislike head-to-head studies because they provide momentum for new entrants that are challenge market dominance. In cancer, where survival is at stake, patients and providers are willing to pay more for demonstrably superior tests and treatments. Incumbents often prefer ambiguity, maintaining a state of equipoise where no definitive advantage is established for the new product.
On Point (c): Study the reaction that we had from several posters when the St Vincent's announcement landed! Find the most upset and negative posters on the matter - and then check where they are invested (even if they claim to be Cu6 holders). Check where else they are invested, and then go and see what they posted in those chats that day.
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