Intermune (ITMN) Conference Call Rundown
So during the Intermune conference call there were several questions regarding the company’s Roche partnership on Danoprevir, but I think what investors really wanted to hear was more information on Pirfenidone. So let me cover the more important parts of the call in relation to the drug. » Read more: Intermune Update on Pirfenidone
Questions for the Intermune (ITMN) Conference Call
So after the rebuff earlier this year from the FDA for Intermune’s lead product pirfenidone, the company will hold a conference call to discuss its quarterly progress. Since there has not been much clarity on how the company plans to come forward I expect there to be several questions on the topic of moving the pirfenidone development program forward. » Read more: Questions for the Intermune (ITMN) Conference Call
Cell Therapeutics (CTIC):
Cell Therapeutics said this morning that they have an agreement with the NCCTG to conduct a Phase II study of their lead product Pixantrone in patients with breast cancer. A couple months back the FDA advisory panel voted against approving Pixantrone for NHL patients citing the company’s failure to run a complete Phase III clinical trial. The company is working on getting Pixantrone into another Phase III trial for NHL patients to try and push it through the regulatory hurdle. » Read more: Daily Pharma Watch
As noted during the April 23, 2010 risk/benefit meeting, the FDA is designing a management tool to further transparency into their drug approval process. The management tool will be formatted in a grid design and will explain their risk-benefit decisions as a baseline for drug approvals. Some of the heavier weighted factors that will be incorporated into the management tool will be the need for a new treatment and the severity of the disease. » Read more: FDA Decision Making Process Revealed (What investors need to know)
So now that we now the FDA’s official stance on Intermune, investors are going to want to have some ideas of what is ahead for the company. For starters, most of this is speculation that I am gonna throw out there, but I’ll give my honest opinion. I’ll also throw out some questions as to what I think should be asked on the conference call. » Read more: Intermune What’s Ahead (ITMN)
Alright Intermune investors, it appears that the worst case scenario has happened. The FDA has asked Intermune to run another clinical trial for their lead product Pirfenidone. Previously, I had put an 85% chance of approval on the drug, based on an analysis I did (here). I am actually left a little stunned, (scratch that I am in complete disbelief), by the FDA’s decision here, because it is clear that the Advisory Panel wanted this drug to get out on the market, yet the FDA didn’t agree with them. » Read more: Intermune Receives Complete Response Letter, Analysis
Intermune (ITMN):
All eyes should be on Intermune this morning, the PDUFA date for their lead product Pirfenidone has arrived. I am expecting a decision out of the FDA today. I will try to keep my readers posted on their decision as soon as word gets out. I have put a $58 price target on the stock for approval and give it 85% chance of approval. » Read more: Daily Pharma Watch (Update in progress)
Alright Intermune Investors, I am posting a quick email exchange from my conversation with the FDA this morning. Per Sandy Walsh, the official in charge of disclosing tomorrow’s approval decision will be Erica Jefferson. I will try to give you up to date information out of the FDA as soon as possible, if they relay it to me. Below is my email conversation. » Read more: Intermune (ITMN) Update (No Decision Yet): My correspondence with the FDA
ITMN : Today I am going to go through a quick rundown of my opinion on Intermune’s Pirfenidone and whether or not the drug will get approved. I’ll be citing a lot of info from the FDA’s panel hearing (here). » Read more: Intermune’s Pirfenidone Approval Estimate : ITMN
Daily Pharma Watch
Intermune (ITMN):
All eyes are on Intermune today and tomorrow. The company is expecting to hear any day now from the FDA in regards to its NDA for Pirfenidone for pulmonary fibrosis. The company received a positive 9-3 vote back in March from the FDA’s advisory panel, but investors are still a little nervous because the drug did not meet its endpoint in one of the pivotal Phase III studies. The PDUFA date is set » Read more: Daily Pharma Watch (In Progress)
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