GD (aka Soxrates?):
Thanks very much for your kind reply and wishing CVM longs good luck (again, you have said you are also a long despite your claim of a 'red flag' on trial design).
Apologies in advance for the length of this post.
Agree announcing results only after the complete data analysis on a biotech is probably unusual (against the norm as you say? don't know whether to agree with that so would certainly appreciate if anyone had any stats on this), but I'll throw my 2 cents in:
1. as others have pointed out, flexibility in the event that we don't meet 10% improvement but there are other positives in the data - secondary endpoints and/or other.
2. keeping all guessing, including the considerable short interest. Certainly CVM can change their 'plan' which was the word used by Geert, and I expect they would if the topline data are good (unless they've told the CRO and ICON to only report the complete dataet/results, which is certainly a possibility)
Agree also they do not need FDA approval for a standard PR, but they certainly want to let them know well before they release the PR. Sending the FDA data would need to be done today to match a pre-market 18 Aug PR. Options activity and volume does not suggest that any announcement will come this week, or so it seems to me.
In your post that I had trouble understanding, one of my question to you is why you raise this issue of the trial design and target population some 9+ years after the trial began. And stated in your post that 'you (CVM) seem reluctant to test in this setting is a red flag to me' does not provide any source - how do you know they are reluctant? They must have considered that option and made the decision before the P2 trial as the target patient population was, I believe, same in P2 and P3.
Although you suggest Geert did a ‘bait and switch,’ it seems that Geert did answer your question by saying they wanted a robust immune system to (presumably) increase the chance of success of MK. Isn’t that what he was saying? Fairly simple reasoning.
You suggest they should have taken the clearly riskier route of testing in a metastatic setting – what if their trial had failed to meet endpoints due to a compromised immune system? Then how would they have conducted the longer trial they are currently running? Funding would have been very difficult to obtain.
I do agree that Geert could have been more diplomatic and clear in his answer to you. His manner was disappointing.
Finally, you suggest that ‘All successful (neo)adjuvant therapies have activity in the metastatic setting.) First off, what successful neoadjuvant therapies for HNC? Are there any? You mention Nivolumab but why isn’t that SOC? I assume that it is currently in the trials you name, but your suggestion that there are currently other successful (neo)adjuvant therapies in HNC is misleading at best.
‘These are all valid points about trial design…’ and you seem not to have researched the literature and other background to their P2 and P3 study design. Certainly there must be some literature/background discussing this exact point on neoadjuvant vs adjuvant therapy in the trial design.
In your interesting prediction, you say “…part of the reason it’s gone on so long is to see the LI relevance compared to your cyclophosphamide mix.” But this is not related to any study endpoints, and to believe the IDMC and CVM kept on with the study was for this relevance does not seem logical. I don’t believe that the IDMC would do this, essentially saying the study is futile but we want to have the science project completed with the LI relevance issue? Makes no sense at all.
AI
