Evidently, the FDA has a very weak Neurology Team incapable of understanding new technologies such as Metal Protein Attenuation Compounds (MPAC)!! The FDA needs to bring in new Neurologists and strengthen the team!! I hope Ms. Woodcock is attending to this. The patients are suffering!!
Given that there has been a substantial amount of testing with mice and in humans, I don't see how the testing in a few dogs is all that relevant. My first question is: How many dogs were tested? Is the answer 10 dogs, 20 dogs, 30 dogs? It is highly unlikely that more dogs have been tested than humans. Also note that there are things that are toxic to dogs and not at all toxic to humans. One example of a toxic substance to dogs is chocolate. Chocolate is extremely toxic to dogs (Kills dogs) but billions of humans have eaten chocolate without any bad effects. Given that the toxicity in dogs showed up in a very small trial (few dogs in trial), I would think that the most likely explanation is that there is a distinct difference in the reaction to the drug between dogs and humans. (Note that the dietary requirements of dogs is SUBSTANTIALLY DIFFERENT from that of humans. The dietary requirements of mice is much closer to that of humans.) Note that no such toxicity was ever seen in mice (or rats) where many more mice experiments were done and the much higher numbers carry much more relevance. At best, the FDA is using the PCH as a "cover your #$%$ tactic and at worst it is using the PCH as a delay tactic to allow other drug companies to narrow the lead Prana has over the competition in order to allow more drugs to get through trials and hit the market. After all, what patient would want to go through a drug trial if a good drug already exists on the market? This is IMHO.
Let's keep the posts with relevant information from getting buried by the maggots' effort to engage the good posters and flood this board with lies and drivel. Please don't feed the maggots with their multiple IDs.
PRAN's Pbt2 is the only drug that reduces A-Beta deposits and prevents Tau Tangles from forming. It will be a Godsend to patients suffering from neuro-degenerative diseases. It is a shame that the FDA has delayed the start of the phase 3 trial by over a year with this bogus PCH based on old Dog studies which used very high doses when we have up to two years worth of data in Human studies. However, based on PRAN's AGM and the recent half yearly report, I am assuming we are close and the the package that is being prepared for the FDA will soon be handed to them. A little more patience is required IMHO.