Bungler, I have been wondering and at times.... looking through various FDA links in the past to look for answers for some of these questions that are brought up re: IF Peregrine needs the ok from a competing Big Pharma that has the patent for a particular drug, but what if the goal of Peregrine is simply to reinforce the "MOA" of Bavituximab, in how it targets PS that is flipped on stressed/cancer cells ? I may be off in this way of thinking.... but here is just one of the sites I found: I am not saying that this paragraph has a direct related but "many" of the exceptions include the same wording to show that the intent is to prove/further prove: "...human physiology, pathophysiology, or biochemistry"
5. Do clinical investigations of positron emission tomography (PET) drugs need INDs? An IND generally would be required for a PET drug investigation, unless the investigation meets the criteria in 21 CFR 361.1. To meet these criteria, the research must be intended to obtain basic information regarding the metabolism (including kinetics, distribution, and localization) of a radioactively labeled drug or regarding human physiology, pathophysiology, or biochemistry, but not intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety and effectiveness of the drug in humans for such purposes (i.e., to carry out a clinical trial) (21 CFR 361.1(a)).
The ultimate goal I believe is to "verify" the MOA of Bavituximab and if Bavi combined with drug "x" decreases toxicities, increases and offers an optimal immune response .... could Peregrine request the FDA to further prove this MOA by additional combination trials for this sole purpose?
I believe on Jan 30 and the combination trial data for a PD-1 or CTLA-4 that is presented, could place the final nail in the coffin for opposing Big Pharma that were trying to hinder Peregrines progress, and finally unveil an MOA that truly allows "cancer immunotherapy" to live up to its name and take off in 2014.
Time will tell.... and I may be off in my reasoning for the combination trials ( for example, maybe the MOA has been proven fully and accepted by the FDA.... but these combination trials would certainly provide further proof and verification )
Final note, in my reasoning... if this MOA of Bavi gains full acceptance--- then is it out of the realm of possibility that Peregrine does not need combination trials for FDA approval with other drugs in the future. This would of course fall in line with the "Peregrine needs no marketing of Bavi" since no cancer patient would want a cancer treatment unless it included Bavituximab. All this would then give further reasoning that no Big Pharma partnership is required.
Many exciting days ahead, hopefully the European market can start the party tomorrow morning.
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