RE: Conference call Liver tox data20 Feb 2019 03:51
Somebody mentioned that in many cases crl's are issued to stall and buy the FDA more time. It has also been mentioned many times that the FDA had published the 13th of February back in November!
However, During the period between November publication and last Thurs, the US government was shut down and federal employees were either furlough or made to work without pay, this included the FDA.
So, I do subscribe to the idea that the FDA was either basically closed (except very essential staff), so this would mean that 5 weeks lost in this 12 week period.
So,I can only come to the conclusion that the FDA either didn't have enough time and/or haven't been able to fully digest and approve. So, for me this will give them time to property evaluate and have some minor query to ask at the meeting!
So, long as we have the answer or can reasonably come up with it, I would expect this to be approved pretty sharpish.
If this is the case it is terrible that people have lost pensions, significant savings or even money that they shouldn't have gambled with, when the FFDA should have informed mtfb that they would extend the period due to extraordinary circumstances.
Saying all this, I think people will realise this and come back, the science is good and Iclprin will save so many lives! GLA