Dear Charles, I'm not sure about your question on the eye products. Alrex and Lotemax already received FDA approval earlier this year and have both been marketed since June by BOL under the banner of being more effective and safer (they were designed precisely to avoid the side effect of intraocular pressure common to other steroid opthalmic drugs). LE-T, the third drug in the loteprednol etabonate family PARS is developing, adds an aminoglycoside antibiotic, tobramycin, to the mix. The NDA (new drug application) for LE-T is targeted to be filed by June 1999. Since it will closely resemble the two earlier drugs already approved, we could have our third revenue stream in place by early 2000.
Where did you get the 6-year to-market estimate for HU-211? It's likely that the company will finish Phase III by the end of next year and have its NDA to the FDA by the first half of 2000. Remember that there is no treatment at all for traumatic brain injury at present, so we should get an expedited hearing by the FDA. If we get approval, we should hit the market by 2001, approx. 2 1/2 years from now. By that point, we will hopefully also be in early Phase III for Tamoxifen Methiodide.
Regards,
Ariella |
