RE: Please stop refereeing to outside material and inferring things from it11 Apr 2022 15:26
Hi RN1MLT,
In support of what you were trying to convey you made a specific claim about what the company said in the annual report/rns/webcast and that claim was incorrect hence my response. I think it is important that we are objective and honest about what has been said, what we know for a fact and what is speculation, as I’m sure you do too.
“My point is made by reading the SEP 21 statement in conjunction with March update and not reading them individually. RCC is the only disease group advance enough in September to give positive signals to warrant spending resources to plan for a phase 3 study.”
How do you know that RCC was the only group advance enough in September?
In order to reasonably make that link you would need to know the in-trial progress of the different groups at that point in time. Correct me if I'm wrong but as far as I’m aware 4D has never released such information or said anything on the matter. That leads me to think that you are making the link based on assumption.
?“On one hand you acknowledge that they are working towards a phase 3 in oncology but it being in RCC is a speculation and then go on to argue that the talk of phase 3 in oncology itself is a speculation.”
When they released the half year report in September, based on what was known at that time I interpreted the statement you referenced as management indicating that the trial is progressing well and that, with the little bit of luck every company needs, their intention is to progress to a pivotal trial in 2022. I didn’t then and I don’t now in hindsight interpret it as management saying that they were already putting a phase 3 trial together, much less make the leap to thinking that they were saying such in relation to RCC. As I’ve already noted, 4D has never released any information or said anything about the in-trial progress of any groups at that point in time. Without such information and however you choose to interpret management's statement, trying to link it to RCC (or any specific group) is speculating.
4D has not yet confirmed that they will be doing a phase 3 trial for RCC. What they have said is that they are going to investigate a potentially pivotal trial with their advisory board. Personally, I do think that they will try to get approval for ICI-refractory RCC, it has met the primary endpoint and they have the safety aspect on their side so why wouldn’t they try for it. Whether they would choose to go the phase 3 route or try to go the accelerated approval route if that’s open to them, who knows. At this point though and regardless of however favourable we might consider the odds of progressing to be, until they confirm what they are going to do we simply do not know for sure.
Given the positive results to date and the frankly fantastic potential that 4D has as a company, I’m comfortable with that uncertainty and I’ll continue to embrace it for the long haul.