Regardless of initial reaction to the start of ASX after some very good days, ADDF’s Executive Director Howard Fillit, MDs statements hit the ball out of the park for me.
“At the time of initiating the trial, we noted that PBT2 stood out as one of the few remaining
orally available agents with clinical trial evidence of cognitive benefit for Alzheimer’s
patients,” Dr Fillit said.
“Since then the relevance of this trial and its design has only increased, in light of the
changing competitive and regulatory landscape for Alzheimer’s drugs in development.”
“The ADDF is proud to have supported this PBT2 trial design that reflects the US Food and
Drug Administration’s new guidelines encouraging companies to look at treating patients
earlier in the disease process.”
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In March we may hear that the two dropouts were placebo participants suffering from depression amongst their trial peers. Wonder how the ethics committee might rule on the Imagine extension trial participation in such a situation...just churning out crazy ideas....don't mind me.
I agree the prevention market will be absolutely huge. Just having researched PBT2 and knowing there could in worst case still be some time before approval, I signed up last week at endalznow org to the prevention trial registry, in some ways as a curiousity to see what information is received on the trials, but as much to see if PBT2 will be in a future prevention trial in my geographic area. It may well be my soonest, and more affordable EVER opportunity to try it. There are 24000 in the registry.
If PBT2 comes around as a stand-alone option I would consider joining a prevention trial If I were found to qualify.
On a separate topic, I also am wary of the recent trend toward forming cocktail trials at this stage of the game, because I don't think enough promising drugs have come down the pipeline yet to play this game with anything other than greed, and big pharma money driving the cocktail composition.
Not one mention of greater risk to the patient in any conversations I have heard advocating this new direction that they seem to already be pushing toward and planning for trials that in my mind will take up resources that a promising new standalone candidate might have emerged with that same resource. Let's evaluate the 2nd gen compounds coming along on a stand-alone basis and first develop a field of promising drug candidates that have some stand-alone merit. Such as PBT2.
The Parkinson's drug PBT434 from their MPAC library in preclinical development funding via the Michael J. Fox 2011 Therapeutic Drug Development Pipeline program appears very promising. It is a 4 Billion market compared to the 1 Billion Huntington Market they have pursued towards early-to-market opportunity for PBT2.
I think PBT434, and the new FDA draft guidelines are aces in the hole for Prana Biotech.
Prana Biotech has set a goal of First-in-Human testing of PBT434 by the end of 2014. It this very end of pre-clinical studies stage there are quite a few companies that partner up at this point. I had recently noticed that GSK is quite adept in the Parkinson's market taking on partnership deals at this point.
But when you see the growth of a company like Pfizer that is now over a 200 Billion, and with many more drugs than Viaga, it is easy to see how someone getting in at this early stage could easily make a fortune large enough to retire on. The fact that Prana has compounds that are effective across multiple Neurodegenerative diseases, and hold promise in other ailments surrounding metal imbalances throughout the body, and for aging - the blockbuster potential could truly be an understatement. In under four months we will have our first peek at what type of trajectory we are on.
I never dawned on my that the NASDAQ composite (if that's the index) exceeding 5,000 hinged on the outcome of this trial, but could be the case ;-)
Eso, hope you didn't quite posting cause someone p*ssed you off. If it was me I'm sure I was just clowning around LOL. If you drew a line in the sand for yourself to enter "the cone of silence" till we hit double digits, hopefully we'll start hearing from you again within another week or so. Don't be a stranger, k!
There is certainly some buying interest for it to be taken down to .615, and then come all the way back up to .655 an trading pretty steady at .65 level. It's nice to see.
Those are good observations.
I also wonder since Prana has not acknowledged any change to the new agent if the change is limited to the AIBL study, and since Prana likely had already started their trial with PIB/PET that they are consistently completing the IMAGINE trial using PIB/PET.
Prana also utilizes a contracted company to perform these scans, so I hold some doubt that Navidea's new compound (I agree likely a superior one) is not part of the IMAGINE trial, but AIBL only.
It would explain a lack of mention, since Prana Biotech has also not acknowledged this change either.
Yes, does seem we put the cart before the horse going for the measly 20B underestimated Alzheimer's market....and would have been better to have captured the broader "old people" market first. LOL, but seriously - hindsight is 20/20