Hi Stocky "and as shareholders, we really don’t want them to put at risk the entire program for some short term stimulus right?" They already did this with Ryoncil...Rule 1 never go early. 'So I think if MSB do stop this trial early...' If endpoints met the DMC will signal "efficacy" to the sponsor, which will trigger the decision to stop the trial early....I'm not sure given the sequencing if MSB can apply for EUA without the trial result. The only way they can get the trial result is if DMC say data shows "efficacy endpoints" reached then proof straight to FDA for approval of EUA. Bit of a tightrope walk I know but given the FDA would look very closely at a sponsor receiving data readouts from an ongoing trial...to back up a case for EUA. Touchy touchy between sponsor and FDA although I feel the timely combining of forces - ie Novartis/MSB would have a wealth of where to from here. https://www.fda.gov/media/75398/download page 33/34 of note Again we ive in strange times...Covid times. Given all vaccine candidates seem to get to peak under the hood and push their version without recourse from FDA for fasttrack to populace. Seems the Novartis crew are a busy bunch so have plenty of depth for FDA negotiation.
No doubt we will have acase for EUA if endpoints met, just whether its a gamble to throw it at FDA without actual readout...never go early. avagoodone.
MSB Price at posting:
$4.47 Sentiment: Buy Disclosure: Held
(20min delay)