LUUUUIIIISSSS. It's the NDA to get approval. They say they will file by the end of the year, but it sounds like it may be a little sooner. Then it's up to the FDA and there's no way to know how long it would take, but if it's straight forward, it'll go quicker. Also, Lidak has the manufacturing facillity ready. We could see sales within a year.
Except for the infamous 1st phase 3 study, the company has been on course. And now with these second phase 3 studies, it looks like little or no time was lost since they used the time to get as much of the NDA ready as possible, and to get the manufacturing and distribution ready. A good recovery. Since Katz owns so much stock, and his guiding of the last study seems to have worked out so well, and he may well show a good business ability, ,,,,so I tend to think that the agreements with the other pharmaceutical companies was probably on the good or very good side. |
