Post by
LittleLadyPhD on Feb 03, 2016 10:12am
Everyone should just take a step back and calm down.
Everyone should just take a deep breath. Yesterday was a big disappointment but most of us who have been following the MCNA story closely knew that Telesta staff had not done a good job presenting their data at the Ad Comm and we knew FDA approval was a 50/50 chance. We were hoping the global BCG shortage would play into the FDA decision and that their earlier involvement in the MCNA study design meant they would overlook the study's shortcomings. Unfortunately, this didn't happen. But MCNA still offers an excellent alternative for this particular group of bladder cancer patients and may even be of use in a wider group of patients in the long run especially if BCG continues in short supply. This is a good take on what happened yesterday and what the future might look like: https://www.stockhouse.com/news/newswire/2016/02/02/telesta-therapeutics-t-tst-slammed-down-76-after-fda-delay
Comment by
thathurt on Feb 03, 2016 10:20am
i agree and on AdCom fiasco i would replace current leadership, stunning failure of leadership really.. ..other issue is failure of TST leadership to get moving on EU approval.. MCNA is no help to BCG shortage unless it is approved for use. MCNA is not help to patients in need unless it is approved for use.. ..PIII redo in US per FDA will cause 4-5 year delay...
Comment by
thathurt on Feb 03, 2016 12:50pm
frogger the contingency plans should have already been prepared and now it should only be execution.. for instance, all plant staff should be immediately laid off and with any business development teams, etc. IMO TST has burnt through a lot of its cash horde..$0.30 is IMO a pipe dream, it was that before CRL as still a chance of approval now there is none