"The current trial has two major design risks. The first is that the primary endpoint is progression free survival (PFS) rather than overall survival (OS) and the second is that there are no US recruitment sites"
This is partly true, however from my understanding the primary end point wasn't mentioned as a concern from US investors.
The concern wasn't that there was no US sites either, it's more the reason why there 'was' no US sites. If we wanted to have sites in the US, then we would need to be screening Patients for the K-rass mutation. However you can run trials outside North America without Screening for it- This has helped cut costs, and speed up recruitment. As 40% of Patients have the mutation and wouldn't otherwise be eligible...
The other concern raised was the inconsistency between the Ph 2 & Ph3 study. As the SOC or the widely used treatment regimen has basically changed since our ph2 study, so my understanding is that the Ph3 has been made to reflect this.
This means the Ph2 & 3 Study have different control arms( Irinotecan (Solo)-Ph2 vs FOLFIRI(5-Fluourouracil, leucovorin and irinotecan)-Ph3... There's also performed differently with the Ph3 study using FOLF(HA)IRI instead of HA-irinotecan (as per phase II)
-Please correct me if my explanation is wrong here Andrew
Andrew has explained why the above shouldn't be a problem, and it certainly shouldn't be in the eyes of an oncologist. However it's something some US investors have picked up on, I'm also assuming that it's something which might not be that favorable in the eyes of the FDA?
"Neo - I'll hope that the market disagrees with me on this, but with some ~15,000 new diagnoses of CRC each year in Australia alone, I don't understand the "milestone" view of full recruitment for this trial, given ACL has displayed an extensive ability to collaborate with oncologists and researchers worldwide."
Perhaps milestone was too strong of a term. IMO it's the fact that we've pretty much kept the recruitment process on schedule( Staying on schedule is a very rare thing for this company), which mean costs shouldn't blow out. If there were delays in the recruitment process( Or any "black swan type event) then more of our cash would be required, cash that we don't really have. Surely the market knowing the Ph3 is fully recruited will create some reassurance for the SP.
ACL Price at posting:
32.0¢ Sentiment: Sell Disclosure: Held
(20min delay)