Good Grief, Azithromycin has resistant rates as high as 50% to Strep Pneumo, which is the leading cause of pneumonia in the US. You might as well flip a coin as to whether it will work. Give me Soli any day. That's why Soli is NOT a "me too" drug. If you don't understand that, you shouldn't be shorting CEMP
If Solithromycin's Phase III trial meets non inferiority against Moxifloxacin it will have met it's primary endpoint and will be a slam dunk for FDA approval assuming no new safety concerns pop up. Clear statistical superiority is unlikely although possible. There is NOTHING wrong with non inferiority in Antibiotic trials designed to show just that. Non inferior IV results will be considered a huge success, and set up Cempra for a likely takeout come 2016.
There will NOT be Phase III IV data next week. We are just awaiting an enrollment update. It will take at least 3-4 months after complete enrollment to get data
CEMP is certainly on Big Pharma's radar. no doubt about it. They understand the revenue potential of solithromycin and yes, your estimates are very conservative IMHO
90% complete on oral trial enrollment. They guided they would not be fully enrolled until 4th quarter at Aprils conference call as they were at 75% enrollment at that time. So they have enrolled 15% more of the trial in the last 90 days. I would guess they could get the next 10% completed in the upcoming 90 days. That would be late October. So, looks like oral trial fully enrolled early in the 4th quarter rather than later and results in early 1st quarter 2015 if not sooner
But they could let us know if the facility has been inspected or not. Has it been inspected and we are just awaiting approval or has it not even been inspected yet?
Vincent, Approval June 2014?? You referring to Calcitriol or Triferic? Triferic will be 6-12 months at the earliest
The RMTI PR did not mention how long they believe the review process will take. Anyone have any idea how long the review will take. My guess is 12 months but CMS could save a lot of money on ESA agents if this gets to market sooner. Will they prioritize it?
For some reason it only links to Yahoo on DRTX although the article pumps CEMP as it's lead.