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Sunday, October 01, 2017 4:54:43 PM
Staccani: It is a shame that while you make several interesting points, your arrogance and self-validating viewpoints make it very difficult to sift through your claims and count them as reasonable. Smart people understand when they do not know things or when they lack perspective. You apparently do not. Please
(1) Scroll up to see who is the moderator of this forum. gr8db8 has been here and arguably been the most active for years as far as I can tell. Only a fool would try to question whether he has been "paying attention".
(2) His point about the exact timing for the 105th event is the same point that Davidal66 made (a neurologist - who you have questioned). It is the same point I have made (a PhD scientist that currently works on clinical trials at a big pharma company). It is the same point that several others have made: Without the actual data, our estimates are fallible. You have brought up some excellent points regarding timing and expected event dates, but without the actual data, let's please recognize that this is still conjecture.
(3) You are making several assumptions. The most obvious is that Avastin will perform right around its historical average. But there are others:
(i) Do you know the distribution of events in the historical trials? Your logic is built on the suitability of using "averages", but what if the events occur in a non-normal fashion? Your calculations might be significantly off.
(ii) You are also assuming VB111 is going to perform similarly to Ph2. Some reasons why it might not are obvious. Other reasons why it might not have been carelessly brushed aside by you. As Davidal (a physician, remember) noted sometimes travel and other stressors associated with participating in a trial can destroy results. Also, for example, opening up the trial to more hospitals just increases the likelihood of processes that were taken for granted rearing their ugly head. Example: Merck ran a Ph2 study that looked amazing out of a single hospital, but in Ph3 it ended up getting shut down by FDA. (http://investors.merck.com/news/press-release-details/2015/Responses-Observed-in-Three-Quarters-of-Heavily-Pre-Treated-Multiple-Myeloma-Patients-Receiving-KEYTRUDA-pembrolizumab-Combined-With-Lenalidomide-and-Dexamethasone/default.aspx)
(4) Median OS means the survival of the 9th longest surviving patient as there were 17 patients in the therapeutic dose arm
Your interpretation of mOS is completely incorrect for your commentary on Ph2 Ovarian results. Median overall survival does not mean looking at the survival of the 9th of 17th patients. That should be especially obvious on the figure you reference because 9/17 patients were still alive at the time of making that figure! Do you understand survival analysis and censoring? Here is a primer: https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=655248
Once all events happen for all patients enrolled, then your mistated definition is correct.
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