Thanks to Smith for coming to the rescue. You have to believe his credibility in his statement that the safety study gave them exactly what they wanted. He is very encouraging about the long term revenue outlook for the MMX drug.
He did stop just short again from recommending it, even though he talked so highly about it's long term outlook. I don't think you can wait until after the drug approval. Certainly the speculators will drive the stock price up significantly before next October's approval.
Maybe he just wants to see this patent infringement case behind us, as I do. It's like the global market problem with Greece. If we weren't just so totally focused on that, we'd see the forest through the trees.
At least I know we will be fine in a matter of time. We all wish that it was now, so we could see it reflected in our account balance and so we wouldn't have to view all of bucksave's posts.
Smith is saying what I already said a couple weeks ago.
Just to add, the FDA required the 6 mg safety study (and not 9 mg), and in a recent meeting with the FDA, everything looked to be in order for the 4th q NDA filing.
Here was my posting with link below (this is a dream buy at these prices, Load up below $3):
"Using the 6 mg dose for safety in UC patients was following what was done with Entocort EC based based on discussions with the FDA. Entocort 9 mg is used to induce remission in Crohn's, while 6 mg dose is for maintenance of Crohn's, but for only "3 months maintenance" according to labeling.
It was already known the 6 mg dose of Budesonide MMX was not the dose of choice for induction of remission (the 9 mg was statistically significant). To do a maintenance trial would require more patients and expense to possibly warrant the maintenance indication. This 6 mg trial was not really designed to have the power to find statistical significance for maintenance therapy, but only to show if there might be safety issues (there were none) and glean any efficacy data (the data trended toward this in 2 categories).
The FDA is very familiar with budesonide through Entocort, and this is a 505 2b trial, so should easily be approved for induction of remission based on the EU and US phase 3 data package. Doctors can do what they want with it after that.
Lialda, another Cosmo MMX product, is already selling in the US, and doing pretty well."