hi GG.
This is what Mozz and others were mentioning. from what I have heard, due to the volume of data and new data that hasn't been in previous submissions the fda have asked that we do an RFI. this takes a little longer than the standard 30 day response we normally get we are FT.
now some will say this is negative and hence we will run out of money and the sky is falling etc. Others will say it's great as we have lots of new things to discuss and it will help with breakthrough etc. I don't know what to think so I am sitting on my hands and waiting for the fda to get back to par and for par to tell us, as they will be legally obliged to.
I have heard that the potential response is in June. but if it's later then it's the fda not par slowing things down and 'missing deadlines'. I think there is a chance we may have a bit of extended back and forth here.
next question - implications for a deal and funding due to the delay ? no deal pre fda reply is a pretty good assumption to my mind.
funding ? well similar to a deal.
so we run out of money in 3 months ? well no. I am quite sure they are working on funding.
so bad news from fda or big delays I think will be a serious issue clearly as we need funding clearly. if we get the things the so called 'fanboys' are hoping for, ie reduced numbers / BT pathway well then I would expect the mood to pick up on HC.
I'm nervous for sure but holding in the hopes the fda (who surely know we are short on cash) went this drug developed and hence we find a path forward in the next 6 months.
I could be wrong and it all goes pear shaped. for those long term investors, we need a bit of luck and a little
more patience. let's hope we are right.
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