Friends: Well, let me post an opinion on how do we become a drug company. Although grateful may be right because there was one phrase within the presentation concerning ways to increase market value, “acquisitions”, they have very little money and it would take a lot of stock at 2 or 3 cents a share. I’ve always had a certain possible, and very plausible imho, scenario in my mind and I was keen to get Hector’s opinion/confirmation on that method. – I was especially desirous after the lady questioned why DNAP would do such a thing as develop drugs. I’m sure some have in mind the process that takes the many years and many hundreds of millions of dollars to go from nothing to an FDA approved drug.
--Don’t necessarily apply this to the discussion going on about the drugs in the Moffet program. However, W2P, I don’t see DNAP needing to fund anything but their own work of collecting and crunching data from trials run and paid for by other collaborators. That is, someone is running and paying for a trial for their own purposes and DNAP is just collecting additional information. Or maybe in another case, an actual trial is not being run; there is just people at Moffit taking the drugs and DNAP is genotyping them and mashing those numbers against the results from each of those individuals. –
Anyway, it seems simple in my simple mind and Hector confirmed this to be one plausible situation:
1) a) A Pharma spends the years and the millions to get a drug through phase III trials but the FDA does not approve it due to a low level of efficacy (only works for 20%) or that it kills some people. – the Pharma cuts its losses and into the trash can it goes. b) An even better situation, for DNAP, would be a Baycol(sp) scenario where the Pharma already was making a billion and had to take it off the market due to deaths from the drug.
2) DNAP, seeing a chance to get the rights to the trash-canned drug without any up-front cash, says to the Pharma : give me the drug and if we can get approval, you market it and give us 25-30% of the revenues (settle for 10-15% if you have to --revenues not profits). Remember, the Pharma has written it off and it’s worthless to them.
3) DNAP pays the company, that the Pharma used to do the study, to take one more step and to gather samples from each of the study participants (they may even have everything needed – samples, releases, etc. - already). DNAP does its thing and genotypes all the samples to determine the genetic makeup of the 20% of whom it works on and the people who have the bad side effects.
4) DNAP then re-crunches the numbers from the trial and from their genotyping and can show 100% of who it will work on and 100% of who will have serious side effects and death.
5) DNAP files a new NDA and waits the year+ for the FDA to approve with labeling showing who should take it and who should not take it. This is quite plausible because the FDA often sends “non-approval,” letters in answer to NDAs, requesting additional data before they can approve. This will just be such “additional data”. It may have to be filed in the name of the Pharma, as a resubmitted NDA.
6) DNAP delivers the approved drug to the Pharma who then happily markets it and DNAP gets 25 cents of every dollar of the $500 million per year revenues brought in by the Pharma for many years.
This is a simplistic view but it is a low cost and quick scenario. Various flavors of this scenario are quite possible. Forget about spending hundreds of millions and many years developing one drug. Gabriel and Gomez know very well what is possible and where the pitfalls lie.
Paul
