Your ignoring the fact IRWD needed to run another large CIC trial with 72ug dose vs approved 145ug post Linzess approval due to intolerability.
The diarrhea rate only went down from 20% in 290ug IBS-C trial to 16% in 145ug CIC trial. It probably won't do much better at 72ug.
The lower dose also probably has much lower efficacy.
From the Seeking Alpha interview:
"Investors are very focused on the Plecanatide diarrhea rate being significantly lower than Linzess' rate. Do you find this to be a problem in the patients you treat with Linzess now?
The doctor made it very clear that he and his patients were not satisfied with current treatment options. Diarrhea was mentioned as a concern, but the most telling point to me was that only 1 in 10 of his patients that start on Linzess remain on it after 6 months. This dropout rate seems a bit on the high end to me personally, but a very interesting data point. Multiple times during the call the expert was very clear that a drug with a superior side effect profile would be rapidly embraced by himself and patients.
How do you currently decide between using Amitiza and Linzess in CIC patients?
He surprised me a bit saying that he uses Amitiza about 2-1 right now in his patients. While Linzess is efficacious, the side effects of bloating and abdominal pain were more than he found tolerable.
What percent of your CIC patients need medication for treatment rather than diet and other interventions?
As a specialist most of the patients that come to him have already tried diet and other interventions. He isn't the first stop for them and OTC laxatives and diet usually haven't worked for these patients. He made the point that the patients in general are very rarely satisfied with any treatment option and "bounce" from doctor to doctor.
Are there any patients you see currently in need of medical intervention for CIC, but not on medication?
It wasn't so much that they aren't trying treatments or are on medication, but that they were not satisfied with what is available. The patients are very eager for a new drug in this space."
Jeez, even Seeking Alpha is out of control pumping our stock!
I wasn't being fair. We only get a handful of these wacky posts on days like this. Most of the posts lately have been directed at the shorts. I understand it is because they were manipulating the price for a long time.
I think this company is probably beyond that. We had a binary event that exceeded most expectations. The short trade around three is kaput.
It might be time to give the short thing a break. not worry too much about everything that could possibly go wrong, and enjoy the ride.
My target for the stock before the latest results was 12. I'm looking to start selling then.
I am very pleased to know the company will be bought soon and the share price is going to the moon:)
It's been a long time since I followed a Yahoo message board.
It means they are making all the right moves to maximize enterprise value.
I've been here before and this is very good new$.
Yahoo message boards generally suckk.
“I am honored to be joining the Synergy board during such an important time in the company’s history,” said Timothy Callahan, “I have tremendous respect for what the leadership team has been able to accomplish in getting to this point and I look forward to working with them.”
“I am delighted to be joining the Synergy board,” said Richard Daly, “The GI market is undergoing rapid growth and the outlook for plecanatide is very promising. I look forward to joining such a professional team and contributing to the advancement of the organization.”
Mr. Callahan is a global life sciences business leader with over 21 years of experience in pharmaceutical and biologic commercialization, most recently with the Actavis organization. From 2013-2014 he served as Senior Vice President, Commercial Operations where he played a leadership role in the transformation of the Actavis brand business into a $7B/yr division with a focus in Gastroenterology, Women's Health, Urology, Dermatology, and other specialty markets. From 2010-2012, Mr. Callahan served as Vice President, International Brands & Biologics Marketing at Actavis, and from 2003-2009 he served as Vice President, Sales & Marketing for the company's Nephrology division. Earlier in his career, Mr. Callahan held positions of increasing responsibility in commercial leadership at Watson Pharmaceuticals and Schein Pharmaceutical. Mr. Callahan was educated at Cornell University and holds a Bachelor of Science degree in Applied Economics and Business Management.
Mr. Daly has over 20 years of commercial pharmaceutical experience working in positions of progressive responsibility in sales, marketing and operations. Recently, Mr. Daly was the President of U.S. Diabetes for the joint alliance between Bristol-Myers Squibb and AstraZeneca. In the past, Mr. Daly was a founding partner and board member of SagePath Partners LLC, a commercial outsourcing provider to the pharmaceutical industry that was successfully sold to Ashfield Commercial & Medical Services in 2013. During his 13-year tenure at Takeda Pharmaceuticals, he served as Executive Vice President with P&L responsibility for businesses across the U.S., Canada, and Central/South America. Earlier in his career, he served in the sales organizations at Merrell-Dow Pharmaceuticals (now part of Sanofi) and TAP Pharmaceuticals (formerly a division of Abbott Labs) in sales, marketing, operations and senior leadership positions at TAP and Takeda. Mr. Daly currently serves on the board of Catalyst Pharmaceuticals and Andean Health & Development. Mr. Daly holds a BS in Microbiology from The University of Notre Dame and an MBA from Northwestern University's Kellogg School of Management.
“I am pleased to welcome the addition of two superb individuals, Tim Callahan and Rich Daly, to our board during this period of significant growth and evolution in our business,” said Gary S. Jacob, Ph.D., Chairman and CEO of Synergy, “Their appointments mark an important step in our efforts to put the right structure and exceptional leadership in place to provide the highest level of guidance and expertise for maximizing the value of plecanatide."
Business Wire - Yahoo Finance
nitabisco - Nice post. This message board has a good collection of posters. Unlike many Yahoo message boards, most people are respectful and don't resort to name calling.
Why do you think the already approved drug (with mediocre tolerability) which was trading around 15 is now trading in the $11's?
You answered your own question and didn't even know it.
BTW: Ironwood only owns 1/2 of Linzess while Synergy owns all rights to their pipeline.
Yahoo really sucks. They put that rec thumb right next to the thumbs down. Difficult to get it right on an iPad.
Sorry about that. Good post.
U.S. share futures leap as Greece offers new reform deal
U.S. stock futures jumped in early Asian trade on Monday after Greek Prime Minister Alexis Tsipras offered a new package of reforms to foreign creditors - a ray of hope for a last-minute deal at the emergency euro zone summit meeting later in the day. U.S. stock futures (ESc1) price rose 0.5 percent from Friday's close to…
rich - That was a great reply. The only thing I would add is the wild card. As Bloomberg reported (and I believe to be the case) they actually started shopping the company pre-Phase 3 results. I could mention other bios that made the mistake of waiting too long and losing out but suffice it to say the best deals for small bios are done hot off the top line results of a spectacular trial.
I can answer your questions and take care of your affairs should there be a buyout while you are away but I'll need your name, address, social security number, account id, and password first.
No problemo. Have a great trip.
Seriously - if the company is sold you'll get the price it was sold at. You don't have to do anything.
"Where will they manufacture this? They better make an additional facility because Ironwood and Actavis have non compete causes with all 3 peptide manufacturers worldwide."
The last thing I would think they have to worry about is how to support demand for a best in class peptide.
A simple Google search turns up loads of peptide manufacturers.
Sound like a lame short argument.
hank - Can't believe all the rubbish I read to get to your post. Appears the 6mg dose doesn't have utility but the 3mg dose did better than in the Phase 2.
I'm holding all my shares also.
Someone correct me if I am wrong, but it is repeatedly posted here that the company might be showing prospective buyers the phase 3 data before it is publicly disclosed when I've believed for over 30 years that it is illegal and any biotech doing so would be open to severe penalties and lawsuits were they to it.
"Now that I think about I hope we don't get results by June 30, 2015. Sounds reasonable that that would mean buyout news coming instead of results. CEO stated Q2 data results phase 3. The Quarter ends in18 days."
Actually, the odds are that if we don't get results by June 30th, 2015 the trial was screwed up in some manner.
I don't understand why most everyone here seems so discombobulated that we haven't gotten the results yet.