Never buy a biotech on any hype created by a PR that features words like "preclinical", or "mice". Never buy based on results from a Phase One study or even a Phase Two study.
And, never, ever buy on any hype created by the news that the all-knowing geniuses at the FDA have deigned to allow a company to someday start a Phase Three study which will cost millions and which, if all goes very well and none of the bureaucrats takes offense any of the company's officials for any reason, will result in a drug approval in five to ten years.
Todays press release illustrates the problem investing in biotechs. It's been almost two years since AnGes halted a phase three trial in Japan because they saw that the drug was working so well. Almost two years. Now, they will have to do it all over again for our FDA . Why? Are Japanese people that different?? Of course not. One must protect one's bureaucratic turf, you know, patients be damned.
One really good thing in the press release, and I would appreciate input on this, is the inclusion of "no option" patients in the trial. This looks like supreme confidence to me, like Babe Ruth pointing to the center field bleachers. If I didn't own the stock, THAT would make me a buyer---though not on the open!
I think you are missing the point of the PR. The good news in the PR was the inclusion of the "poor option" patients - this expanded the patient universe substantially, which will allow the enrollment period of the trial to be shortened substantially. The fact that the FDA allowed them to include the "poor option" patients probably means that they were impressed with the safety and potential efficacy that Anges had from its other trials. I'm guessing if the SPA did not allow this new patient group to be included, they probably would not have announced anything at all - it really is a non-event.
Two things: "no option" patients are usually goners, so the FDA relaxes a little on them re safety.
Second, I agree on the first parts of your warnings, but P2 is a different ballgame. Although it is only meant to test dosage, you get indications of efficacy as a by-product. Early stage biotechs try to get past P2 successfully before looking to sell or partner, that's where they get the best deal. P3 is very costly, so they try to get somebody else to pay for it, and good P2 data is a powerful selling point.
Agree on "no option" patients, but that is why companies don't usually include them in trials--they can screw up the stats. Also, Phase Two is indeed important, but investors should ralize approval is still years away.
IMO Naked DNA is "bleeding edge" in the eyes of FDA and has not been used at scale in humans. NIH has granted orphan drug terms for Vical-developed vaccines because the addressable market is too small for big pharma to pursue.
"no option" PAD patients is a small but costly/challenging population. For the FDA to prioritize this Phase 3 trial, the end point objectives must be clear and reasonable in quality of life.
IMO "no option" PAD patients have a "systemic" problem, just like metasticized cancer patients (incl. dogs). The FDA sees promise in this novel, Naked DNA approach for achieving systemic efficacy that's also safe.
for what it's worth, my opinion.....
NOTE ALSO: In Vical's dog cancer approval PR from yesterday they said there's no data on additional months of dog survival because over 50% of the treated pooches are still alive!!!!! What if the PAD drug for "no option" patients systemically and therapeutically restores patient health???!!!!! Now that's a Holy Grail story!!!!