Talk:Inspire Pharmaceuticals, Inc. (ISPH)
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Prolacria has received 2 approvable letters from the FDA. The company performed another phase 3 trial in response to the first approvable letter, but fall short of the primary endpoint of corneal clearing, but met most of other secondary endpoints. Based on this latest trial, FDA issued second approvable letter in 12/2005, for which the company responded with more data on 3/28/2006. If the FDA approved the drug based on this response, the stock will surely appreciate significantly. However, the project might be in jeopardy if the FDA required the company to perform more phase 3 trials. I expect the FDA to response within the next few months. As I mentioned above, the downside to negative FDA decision is limited at ISPH’s current valuation.
I also find ISPH’s other candidate, denufosol for treatment of Cystic Fibrosis(CF) attractive. It recently entered phase 3 trial, so I don’t expect much newsflow on this drug for the next year. The drug provides novel way to treat CF, for which there is limited treatment option. Currently Genentech’s pulmozyme which is regarded as the best in class treatment for CF makes about $220 million in sales.
I expect the ISPH to stay stable until there is FDA action on Prolacria, especially whether more trials will be needed. An FDA approval might appreciate the stock price to $7-12 range (based on price before FDA approvable letters).
--Khartand 15:28, 10 November 2006 (PST)
Stock Jumped after Diquafosol Update
So The stock jumped to around $7.40 (have since tapered off a bit to $6.44) after the company announced that the FDA was willing to meet with the company again regarding Prolacria. [1] So does it mean that the market is expecting good news this time around?
--K Hartandi 11:40, 1 February 2007 (PST)
