Look for analyst upgrades in the next few weeks. European partnership sounds pretty definitive. Takes dilution out of the equation IMHO. Don't forget this was a lead article in JAMA a few months ago and 92% of infectious disease doctors express high interest in Tedozolid. The ID docs will drive use of this drug. Any analyst assuming FDA approval in 12 months ( 90% chance IMHO) has to see this at least a billion dollar market cap
No way the FDA will take 8 months to approve Tedozolid. Data is pristine, important medical need, first approval decision after GAIN act passed. No way they take 8 months to approve, it is politically impossible.
Did a greAt job trying to get Trius attributes explained to a fairly ignorant Cramer Very positive about EU partnership possibilities. I would not want to be out when that partnership is announced. I expect capital from partnership rather than dilution!
1. Asian partner Bayer - starting trials in Asia
2. Tedolizid NDA later second half NDA. 8 month priority review
3. Mid 2014 PDUFA expected
4. Broad spectrum gyrase antibiotic in clinic early 2014 (this could meet huge unmet medical need)
5. EMA filing 1st half 2014
6. FDA/EMA/China single 700 pt global lung study starts before end of year 2013, site selection underway
7. Tedolizid phase III study lead article in JAMA 2013
8. No interaction with MOA's, SSRI's
9. 6 month safety data pristine, expect final 9 month safety data in next 1-2 months
10. Stat sig less side effects than Zyvox including less GI, platelet suppression, and optic/sciatic nerve damage
11. Hired commercial VP - physician/payor/pharmacist surveys predict 29% initial market share based on efficacy/compliance/side effect profile. 92% of infectious disease docs expressed high interest in Ted (8-10) on a scale of 10. I expect ID docs to drive the use of Tedolizid
12. Announced plans to hire 125 US sales force PRIOR to PDUFA DATE
13. In Q&A CEO stated "robust discussions" with potential partners and expect to "announce something by the end of the year". The moderator announced the end of the session after that last quote so no follow up given as to whether he was referring to US or European partners
14. Well capitalized 84 million. Runway Q2 2014
Have I mentioned that I like this company???!!
Did anyone hear the last question in the call regarding potential partnering. Not sure if it referred to Europe but Stein seemed to answer that there were "robust discussions" regarding potential partners
I love Tedolizid for gram positive infections and believe it will bear much fruit over the next 12-18 months. To me the next step with TSRX gram negative product could be a real game changer as drug resistance to the 'penems could be even more clinically important. Does anyone have any insight as to when Trius will be able to enter Phase I trials for the gyrase inhibitors? Would appreciate any constructive input
Sentiment: Strong Buy