I believe an NDA can take as long as a year, but since Magainin seems to have proceeded well this time with th e tests (unlike the impetigo tests), things should go well. They have collected sufficient data from their tests, their drug demonstrated no toxicity, and the benefits seem to suggest that drug is a suitable choice over oral antibiotics. The question of procing and supply may be a drawback to market entry, but probably only temporary. Medimmune wasn't prepared to distribute their drug after approval, and they could not meet the demand this past fall. I think that Magainin - with their partnerships, should not face this problem, only the questions regarding royalty arrangements.
I still believe that if Magainin passes this test, ie. approval of their first drug, that (unless the company is swallowed up by a large company), Magainin may be the blockbuster company 2 or 3 years from now. Magainin has the potential to be one of the major drug companies in the world. I believe that their new discoveries dwarf their early products - such as the one being tested now for diabetic ulcers. If this makes it, and it looks fairly positive that it has, then their discoveries from the squalamine and others - magainins/peptides that are far more powerful, should rock the market.
Anyway, I've been waiting for over 5 years now, what's another year or 2?
Good luck,
Shep
I don't know if the company can even venture a guess as to how long the process should take, but I would guess that we should here something this summer. |
