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mpreorder

02/14/18 2:20 PM

#54396 RE: Chemist823 #54365

Love this quote from the article. Just started reading it, but it deserves to be discussed here:


Over the review period the number of
“unsuccessful” CMAs was slightly lower (22)
than of CMAs granted (30). In all cases a reason
for not accepting conditional MAs when such
possibility was discussed by the CHMP was
consideration that the benefit–risk balance is
negative, only in some cases complemented by
the conclusion that other criteria1 for granting
a CMA were also not met.



Soooo...if they did a good job of meeting all the criteria for submission, it will come down to a risk vs. benefit analysis, as is always does. We KNOW the risks of our vaccine are minimal, but the long term risks are unknown. (I hear echos of Terri H....ug) BUT, so long as axal shows that it will PROLONG LIFE, which IT DOES, this should be a no-brainer. Even IF there are some longer term side effects, it still has been shown to prolong life.

hovacre

10/30/18 10:47 AM

#84602 RE: Chemist823 #54365

I had similar feelings, but they announced that they were pulling the EU application. So stats on CMAs aren't going to be worth much anymore for Axal