Saturday, August 15, 2020 2:10:18 PM
view.
Here is another view tampering our overwhelming confidence
of success:
***********
Soxrates
Why have you gone for post resection tumours as the primary study group. To my knowledge no new drug in a adjuvant setting has ever shown any benefit that was not demonstrated in a metastatic setting. You would have had a quicker event rate in a metastatic setting, got an answer sooner and might be able to help patients earlier. Would have been less market share.
In addition we’ve seen various cytokines therapies tried previously, interferon, vaccines also with modest effect sizes as best. Why do you think this is different. Was the phase 2 that really shocking?
Finally you must know that having the IDMC advise not to stop your trail well after the expected median survival doesn’t necessarily mean that you’ve got much better survival from your drug. It purely means there is not enough survival signal of benefit or toxicity to be sure either way of benefit or futility. What this means is that if your comparing with SEER data which are all US cancer patients your inclusion criteria have probably been incredibly selective for fit well people or indolent biology. This will massively skew the generalisation of you trial.
Geert:
You must be from one of the shorts who shorted 2 million shares starting at $3 and who just does not want to let go. Like a rabid dog. They have gotten almost all of the science wrong because they simply do not read. What we are doing has never before been done. If successful it will improve your chances of being cured. Are you telling me that you prefer the activation of an immune system that has already been destroyed to one that is still fine? Re the SEER data, it was all patients with the same tumor staging etc as we have in the study. You are like a movie critic who has never made a movie in his life. Try doing something that betters mankind.
****************
I agree that Soxrates is 100% correct on comments below without knowing
the interim results on IDCM advising trial continue:
"Finally you must know that having the IDMC advise not to stop your trail well after the expected median survival doesn’t necessarily mean that you’ve got much better survival from your drug. It purely means there is not enough survival signal of benefit or toxicity to be sure either way of benefit or futility. "
The most recent CLSN PR the first interim look was HR 0.77,
DMC advising to continue, second look HR 0.904, passed the
pre-defined futility bounds of HR 0.90, advise stopping the
trial and let CLSN decide what to do. If the second look
HR is 0.89, DMC will advise CSLN to continue trial, but HR
0.89 is way about final HR 0.75 for success. IT_MATTER's futility HR may be 1.00 and a interim
look HR 0.98 gets the trial to continue. It is mis-leading
for CEO Geert to highlight IDCM advising continue the trial
as very bullish sign unless he gets the message the interim look
HR is <0.9. looking at the other way,
Geert is so positive about continue the trial, the hidden message
is he knows what he talking about, that is what I have done before, IMO.
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