RE:RE:RE:RE:RE:RE:RE:Intercept slips due SAFETY of OcalivaThe delay in releasing the Q3 financials coupled with the pre announcement of the bad sales results indicate that the odds of submitting the NDA are high imo,The CC will be about the future and not on the sub par results but at the same time I hope they adress the sales trajectory for the coming quarters .....We need soon 20 million in Quaeterly sales trending towars 25 million by 3 rd Quarter 2021
SPCEO1 wrote: Based on what the company has said on this subject, sometime this week would be likely. The fact that they chose to release their Q3 financials later than normal tells me they are likely trying to have the protocol submitted by10/15 so they can announce that at the same time. But, these things are pretty complicated so don't be surprised if we have to wait a bit longer than 10/15.
ggg088 wrote: Who can estimate the time of the submission to FDA?