I'm not sure what you mean about it being illegal for her to call/ask. Unless there is some obscure federal statute that I am aware of it isn't illegal to for the sponsor to ask the DSMB for an update on when they will complete their evaluation of the trial data and even why it is taking longer than anticipated.
"Independence of a DMC depends on the relationships of its members to those sponsoring, organizing, conducting, and regulating the trial..... Independence is defined on a continuum. DMCs are rarely, if ever, entirely independent of the sponsor, as the sponsor generally selects the members, gives the committee its charge, and pays committee members for their expenses and services.....Additionally, while sponsor involvement in looking at comparative data threatens independence, sponsor representatives, study statisticians, and study investigators may contribute valuable perspectives regarding the trial that may not be available to the committee from more independent sources. With regard to sponsor/investigator involvement with the DMC, this tension is best resolved by permitting interaction with the committee in a carefully defined and limited manner, as described in Section 4.3.1.2. The involvement of such individuals with the DMC will typically be limited in terms of what interim data may be viewed, which sessions may be attended, what topics may be discussed, and what roles (e.g., observer, consultant, member), may be played."
The biggest concern is to not unblind the data as that could in the eyes of the FDA invalidate the trial.
Maybe I misunderstood you? Anyway, I try to bring humor to this as much as I can. I use to post over on the Yahoo board and once there was some discussion about Linda putting down some serious cheese for website domains. The discussion was about what it could mean for the company. Here was what I wrote...maybe you will find it funny too
Top 10 reasons Linda bought the cancervaccine domains:
10. They were buy one get one free and everyone knows that “soccer moms” (a quote from the molester) love a good sale!
9. NWBO thought they could get a little bump in the stock price so that insiders could dump their shares for a slightly smaller loss!
8. Doctors really like to have their pictures on websites administering a vaccine to terminally ill patients they know doesn’t work!
7. The websites will be used to sale cookies and brownies to raise funds!
6. The websites will make it easier to auction off equipment after the bankruptcy!
5. Linda bought the domains right after having a big cup of NWBO special blend KoolAid.
4. Linda left a college intern in charge of marketing while she was in Venezuela trying to score some Chavez tumor cells for a new vaccine marketed to latin America called DCVax-increible
3. Linda lost a bet with the IMUC CEO and had to buy the domains for their vaccine.
2. Linda is going to sale them for a premium to another immunotherapy company..after all she has to do something to keep the lights on!
And the number one reason Linda bought the domains is…
1. She just needed a couple more big purchases on her SkyMiles credit card to ensure she has plenty of miles for last minute tickets out of the country when this all implodes!
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