OK, for dormant therapies, we've often been frustrated by a lack of study of repurposing old drugs for ALS since they aren't commercially attractive to drug developers. Some examples of how MODDERN Cures features work would be so helpful!
Is it correct that the dormant therapies must be things that have never made it to market? Are old drugs that were on pharmacy shelves for other indications part of the MODDERN Cures Act?
1. What if there is a drug that is within a year of losing its patent and the manufacturer holding the patent decides to pursue testing of that drug for ALS? It will take years to test the drug for ALS. What happens? What does it mean to waive the old patent rights? What does the 15-year period of "data exclusivity" mean?
2. What if there is a drug that is within a year of losing its patent and another manufacturer is interested in pursuing it for ALS? How would that work?
3. What if there is an old drug whose patent protection has long since passed. Can it get new patent protection with this?
We will be dynamite salespeople if we understand the features, advantages, and benefits in some real-life situations that relate to people with ALS.
And does the following link mean that the companion diagnostic features of the MODDERN Cures Act have al been taken care of? http://capwiz.com/alsa/issues/alert/?alertid=63177606
Thanks to whomever can help.