He said in the first quarter, which is not the end of June but between first of July and end of September. Someone else said end of fiscal year.
EUGENE SEYMOUR: Humans. Our plan is to take the first drug and what the first drug is going to be I’m not sure. Could it be HIV? Could it be Influenza? Could it be Dengue? Don’t know yet. We’ll decide in the next couple of months. We first go to the FDA sometime after the beginning of the year, in
the first quarter. That is called the pre-IND. An IND is an investigational New Drug Application. They give you guidance. They say, we want these studies and those studies. We want a 1000 people in the clinical trial so we know when we file what is called the IND, the request to start in humans, we’ve done everything that they have asked. I have been in touch with companies that manage trials around the world in order to get the lowest pricing. These are not 500 million dollar trials like cancer. Cancer trials go on five, six, seven years. These don’t. These trials are over very quickly because each of the diseases that we are attacking only has a natural history of a week or ten days or two weeks; except Hepatitis C and HIV which are more of a chronic disease – and by the way, I’ve been invited by the Ministers of Health of two West African countries to come over and start treating people whose viruses have grown resistant to the triple combination therapy. Now I’m just beginning to investigate the Compassionate Use Rules, to see whether we can do this. And as soon as we have production capability to make enough material to treat people and I get a clearance from the FDA to do this, I’m going to Africa. My goal is to treat these people who are now, the drugs aren’t working for HIV, and achieve the same results we’ve achieved in animals which we’ve reported have been extremely exciting and we describe what we’ve accomplished as creating a “functional cure”. That is eradicating the virus to the extent that it does not cause damage to the person anymore. Not necessarily getting rid of every last virus particle, but these people can live a normal life and it is as if they have a chronic disease. Now, that is one goal. I have a more ambitious goal having been in the HIV treatment arena for thirty years. I
want to eradicate the virus completely. I think it is possible. We have to prove it and maybe I’ll be wrong, but on the other hand, that is my goal, to eradicate the virus completely. With diseases like Dengue, I think we can do that. Unfortunately in Dengue, there are 100 million cases of Dengue a year and a certain number of people when they get re-infected with the virus, develop a fatal disease called Dengue Hemorrhagic Fever and our results at University of California Berkeley have been quite good in animals who have been especially designed to show the symptoms of Dengue Hemorrhagic Fever. I’ve been invited by the Health Minister of a South American country to come down and treat people who would ordinarily die of Dengue Hemorrhagic Fever, sometime next year. We are going as quickly as we can to find the space to build a manufacturing capability so that I can go off and do those things.
Influenza transmission and replication simply explained:
