Hold the best stocks in a particular sector (strong stocks with earnings). SNTS fits this description for small pharma/bios with a BIG pipeline about to yield fruit. Wall Street criminals took cheap shares from weak hands yesterday.
I have not ever seen a case where labeling has been given before approval, but I have been keeping up with DD and listening to CC's and reading PR. So here are some summary points to consider and mull over:
The original delay (Oct 16 PDUFA move to Jan 16) was so a particular regulatory branch could investigate some of the records for clinical sites around the world (this appears to be a normal part of the review process and SNTS did send this originally with the entire package from what I have heard in presentations per SNTS). There has been some change in the process that required a submission of the data to the other particular branch doing the inspections (from what the company has said at presentations). The data is known by the FDA, so it doesn't change anything used in evaluating efficacy, just more of a compliance formality, IMO.
At the same time, the review of the data for actual approval has been going forward. The labeling could be prepared in December according to SNTS, and then they can maybe proceed with preparing labeling documents, packaging, and training of reps., etc, to be be prepared for proposed mid Feb launch, per SNTS CC.
All of his is my interpretation and you can check by listening to CC's or doing other DD. I am thinking if labeling is approved it is likely a positive sign, but this is a new thing, so anything is possible.
I would like to hear what others think. Have any of you seen labeling approved before an actual PDUFA approval in any other cases?
I am new to message board. Recently bought SNTS after taking profit on ARNA and getting burned on DVAX. I only wished I had found the stock earlier. I am in for long hall on this one. Seems like a bargain at these prices with rev stream and existing drugs plus impressive pipeline. Uceris looks like a go to me, I'm a physician but not a biotech investor guru. Zegerid and Glumetza are staples in my eye. Very intrigued by data on Cycloset from AHA. Any input on your feel for likely approval would be most appreciated.
Cycloset sales should continue to grow nicely. Cycloset - An anti-diabetic drug out now with trial data supporting improved cardiovascular safety in diabetics (this is huge and should move up on more formularies). Additionally, SNTS has an expedited patent application in for Cycloset (may help protect from generic competition). The patent may be issued in not too distant future.
For Uceris, there is statistical significant efficacy for Induction of Remission. The other current 3B trial in progress will take a while and possibly lead to expanded label through sNDA for use in combo with 1st line treatment (amino-sal) in patients difficult to maintain. The approval for Uceris in the US is pending PDUFA (505B2 pathway), so PK correlation is used for comparison of safe / effective blood levels. A lot is known by FDA (Entocort EC already approved and safe) and they have helped SNTS along with suggesting safety trial (long term w/ 6 mg, no issues regarding safety). There were no issues with the indicated effective dose (9 mg) for short term dosing (ie- 1 month) to induce remission. Entocort EC delivers the drug earlier in the colon to treat Crohns disease where MMX technology in Uceris delivers drug very late in the colon to the area affected in Ulcerative Colitis. Budesonide is active locally in the intestine and is rendered inactive systemically by metabolism so known use for local admin to intestines fine. Labeling may come out early (in mid-Dec, per SNTS latest earnings CC). That would give an indication of possible coming approval IMO. We would likely see higher prices on that news.