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Still long and accumulating
This kind of move has happened before .. Patience is key
I believe this stock is undervalued. I never thought there were so many flippers here. Today saw many of them were selling. Lol
I believe this stock will hit harder after the news today.
just imagine if PBT2 hits all hospitals. Don't be surprised to see it one day 10$+. Only a drug alone on time can make a 50$. It needs patience!
I do not understand why some people are so bitter why can they try and be patient. you mentioned they have 4 drugs that in itself is positive now today i noticed low to normal volume after midday with a close of 1.39$,the downside from here should be little considering the intra day low was 1.31$,im new to biotects but this stock has ben around for a while so i baught some shares,good luck to all.
According to your statement all pharmaceutical stocks are pump and dumb.
Gene had a run from 1$ to 10$. Bioc 1-5$.
Aveo today, reached level 3.5 by midday. Next turn, Pran!
When other biotecs dont have a drug yet, Pran has four drugs. And the "pump" today, according to you, came from the news. Shorters who were stuck from the dilution got out. Glad they did. Lol
closed RED! PUMP AND DUMP! stay away. was over $12.00 in 2014!
People might be very stupid to short this stock. With all those buys in the morning! God! I hope you don't regret when this will run HUGE!!!
I believe we gonna have a run of GENE and BIOC. Mark my words!
How high can we go i wish i would have baught more the low on the stock was only around 1.10$ we could easily hit 2.50$.
News out - EMA COMP minutes
Minutes from the COMP meeting with positive opinion for approval by EMA
13 May 2015
EMA/COMP/209468/2015
Procedure Management and Committees Support Division Committee for Orphan Medicinal Products (COMP)
Minutes of the 14-16 April 2015 meeting
2.2.3 5,7-Dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride for treatment of Huntington’s disease, Prana Biotechnology UK Limited -EMA/OD/017/15[COMP co-ordinator: A. Andric]
The Committee agreed that the condition, Huntington’s disease, is a distinct medical entity and meets the criteria for orphan designation. The intention to treat the condition with the medicinal product containing 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride was considered justified based on pre-clinical in vivo data and preliminary clinical data showing improvement in parameters associated with the condition. The condition is life-threatening and chronically debilitating due to severe behavioural and cognitive disturbances, progressive motor dysfunction and potentially fatal complications. The condition was estimated to be affecting approximately 1 in 10,000 persons in the European Union, at the time the application was made. In addition, although satisfactory methods of treatment of the condition have been authorised in the European Union, the sponsor has provided sufficient justification for the assumption that the medicinal product containing 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride may be of significant benefit to those affected by the condition. The sponsor has provided preliminary clinical data that demonstrate an improvement in a relevant parameter when the product is used in combination with tetrabenazine. The Committee considered that this
could constitute a clinically relevant advantage. A positive opinion for containing 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride, for treatment of Huntington’s disease, was adopted by consensus.
The sponsor has provided preliminary clinical data that demonstrate an improvement in a relevant parameter when the product is used in combination with tetrabenazine. The Committee considered that this could constitute a clinically relevant advantage. "
Wonder which relevant parameter that was that caused the "clinically relevant advantage?" To me this indicates that a team of experts agree PBT2 may be disease modifying. Huge!
Welcome to the world of biotechs...
I'd like to see your reasoning if any
And your point is?
this stock has already been pumped and dumped. $13 to $1!
there's a reason for this
Aftermarket is going more up, 1.51.
Go $$ Pran $$
Great, so we can see some profits now.
no reason for this to go higher
Probably so - they had an ATM facility to issue ADRs for cash - not aware if they did that but seems like it's done for now
You think the delution is over?
I hope so. Been waiting for three months.
This is just the beginning
Yeah, go $$$ Pran $$$
You n me both :) pran$$$
Great movement today. I hope it continue like this tomorrow!
Hope you're short
I've been loading up! PRAN is headed higher!
Significant buying here and in australia tonight. Something might be cooking.
PRAN uptrend to continue - significant move expected
Neurodegenerative Diseases Market to Grow at 4.7% CAGR to 2019
DALLAS, May 14, 2015 /PRNewswire/ --
The Global Neurodegenerative Diseases Market 2015-2019 research report says reformulation of marketed drugs is boosting the growth of neurodegenerative diseases market during the period reviewed for forecasts in this research.
++++
According to this neurodegenerative diseases market report epilepsy represents a high level of unmet medical need in terms of the absence of any disease-modifying treatment. Currently, drugs used to treat the disorder are intended to treat seizures and fail to check the progression of the disease. These drugs cannot reverse the neuronal damage incurred by the patient.
+++++
The key drivers of neurodegenerative diseases market discussed in this research include unmet medical needs, increase in patient population, promising drug pipeline and special provision for rare diseases. Market trends like reformulation of marketed drugs, emerging treatment options and increase in public awareness. Analysts have conducted in-depth analysis of the impact of market drivers, challenges and trends featuring data on product segmentations, vendor shares, growth rate by revenue and an evaluation of the different buying criteria in the order of importance. To calculate the market size, the report considers revenue generated from the sales of various drugs used in the treatment of neurodegenerative diseases. The market includes data from the sales of various drugs used in the treatment of: Alzheimer's Disease, Parkinson's Disease, Multiple Sclerosis, Epilepsy, Huntington's Disease and Amyotrophic Lateral Sclerosis.
Companies like Biogen Idec,+++++Prana Biotechnology++++
Good read - thanks for posting - GO PRAN@@@@$$$
Very good for Prana not good for Biogen neccessarily -- "small group of patients sharing certain genetic traits" for Biogen the worst SAEs were in ApoE4 positives. We know that with 77% of the IMAGINE population ApoE4 positive and no reports of ARIA-E and greater than 2.5 SUVR they saw significant reductions this approach would benefit PBT2! Very important distinction between Biogen drug and PBT2. Typically around 65% of the AD population is ApoE4 positive.
and, hmmm "refining them and obtaining regulatory approval for their sale in the EU," sounds like that might be a possibility with EMA approval around the corner likely by the end of May.
Rx for Patients and Big Pharma: Speeding Up the FDA
The 21st Century Cures Act would speed the drug-approval process and allow the desperately ill to try promising experimental cures.
By JIM MCTAGUE
May 8, 2015 7:35 p.m. ET
Congress is racing to produce a panacea for all that ails us—including nettlesome barriers to investment in the pharmaceutical and medical-device sector. The 21st Century Cures Act is rapidly moving through the House Energy and Commerce Committee with bipartisan support. It’s viewed by medical professionals as the most revolutionary change to the Food and Drug Administration’s approval process since the National Cancer Act in 1971, in which Congress and President Richard Nixon declared all-out war on that dread disease.
The intention is to mark up the Cures Act by May 30 for a floor vote in June. A Senate committee has taken up a complementary bill. The rosy scenario: The House and Senate pass a reform bill before the end of the summer.
But that would not be the end of it. An appropriations bill would have to pass in both chambers to fund the new measure. The House bill increases funding for the National Institutes of Health, from $30.3 billion now to $31.8 billion in 2016, $33.3 billion in 2017, and $34.8 billion in 2018. Even the most cockeyed optimist can anticipate resistance to a budget increase by the House’s vocal bloc of fiscal conservatives. But the bipartisan House coalition that supports the measure will no doubt roll them, with the bill arriving on the president’s desk for his signature by fall.
BOTH THE HOUSE AND SENATE MEASURES aim to streamline the discovery-development-delivery cycle to accelerate the pace of cures, without introducing recklessness into the process. Speeding research and approval, in turn, should significantly lower the costs and risks of developing medicines, former FDA Commissioner Andrew von Eschenbach told me last Wednesday at an event sponsored by the nonprofit Alliance for Health Reform.
A faster cycle, he said, should particularly appeal to venture investors, who have been moving away from the space because of skyrocketing development costs and lengthy wait times that often are a consequence of an outmoded FDA approval process. “When the business model makes sense, then the whole system benefits,” he said. Capital, as Barron’s readers certainly appreciate, makes civilization go round.
The pharmaceutical, biotech, and life-science industries, of course, have been among the stock market’s brightest stars this year—in part, I suspect, because of favorable prospects for this legislation. Although Republicans and Democrats disagree on almost everything, both parties and the president strongly support improvements to the plodding, overly cautious FDA approval process. Nearly as important, the House bill also has the vocal backing of patient groups and pharmaceutical and medical-device manufacturers. Credit this to the efforts of the bill’s sponsors—Fred Upton, the Michigan Republican who chairs Energy and Commerce, and Diana DeGette, a Colorado Democrat on the committee—for engaging all of the stakeholders last year.
We the patients, of course, are intended to be the primary beneficiaries of the legislation. But there are economic benefits for the nation, as well. Absent an overhaul of the FDA’s approval process, there’s compelling reason for pharmaceutical and medical-device makers to shift some research jobs from the U.S. to the European Union, which boasts a less burdensome approval regime.
In fact, von Eschenbach wrote in a 2012 Wall Street Journal op-ed piece that a shift was under way. He cited a 2012 California survey of life-science CEOs, which found that 80% of respondents didn’t consider the FDA’s approval process to be the world’s best and that 81% believed that by 2017, some other country could surpass the U.S. as the nation that bestows a sort of global Good Housekeeping seal, potentially engendering a mass exodus of research-and-development jobs.
An expert tells me that some clinical-device manufacturers are seriously discussing developing their products in the U.S., refining them and obtaining regulatory approval for their sale in the EU, and then manufacturing and hawking the final product in China, which has the globe’s fastest-growing middle class. The companies are reluctant to pull all of their R&D from the U.S. because we still lead the world in intellectual capital by virtue of our universities and cancer and research centers. No other country can match our current research infrastructure.
THE MOST IMPORTANT PROPOSAL in the House bill is the required emphasis on “biomarkers” by the FDA when it is determining the efficacy of a drug or therapy. This would encourage the agency to approve a product that works in a small group of patients sharing certain genetic traits. The current process requires medicines to work reliably among a larger, more general clinical-trial population in order to be approved.
The approach is a keystone of the smaller, $215 million Precision Medicine Initiative that President Barack Obama unveiled in his 2015 State of the Union address. A one-size-fits-all-approach to developing treatments, the Obama administration said, can be “very successful for some patients, but not for others.” And the administration added, “This is changing with the emergence of precision medicine, an innovative approach to disease prevention and treatment that takes into account individual differences in people’s genes, environments, and lifestyles.”
To aid in the discovery of breakthroughs, red tape that discourages NIH scientists from traveling to conferences to share ideas would be cut. And a private-public nonprofit corporation with NIH representation would be established to foster scientific collaboration among the research community. During the product-development phase, companies would interact with the FDA early, to ensure that their products were in line with regulatory expectations. The aim would be to reduce the multiple rounds of FDA reviews that often occur. And during the development cycle, desperately ill persons would have easier access to highly promising experimental drugs.
Upton told the New York Times in April that the bill is an opportunity for Congress to “do something big.” Make that “do something gigantic.”
http://online.barrons.com/articles/rx-for-patients-and-big-pharma-speeding-up-the-fda-1431128153
It was back in late 08 that I first started tracking PRAN , got in early JaN 09 in the $1.50 range and locked my gains back then in the $3-4 range, missing out on the rally to $14 few months later .., I'm back in now and truly think the science has matured since ... My strategy this time around is longer term unlike my first taste of PRAN
So you've been in for a while? It's clear the science is very strong.
It does seem that way - at least a 10% gain since the news and it has held that going into the close of this week - reminds me of how PRAN behaved way back when it ratcheted up over night but it took a while, weeks /months but it was worth the wait
Probably a good plan. There seems to be some accumulation going on quietly. Higher than normal volume last night on the ASX but closed flat. Since EMA orphan recommendation seems like the tide is turning. We are also getting closer and closer to the IMAGINE trial announcement which the company has said May/June timeframe but I wouldn't be surprised if they came in July.
True - it's testing $1.30 again - maybe break it?
Yes it did a bit. But on fairly low volume.
No I don't believe its typical.
That's amazing - is this a typical size drug library at small pharma companies ?
Wow!! Didn't realize
At this SP it has pretty much been de-risked. The market isn't expecting anything out of the extension trial. With over 1500 compounds in the library and many shots on goal possible right now with PBT2 and PBT434 and now 1033 is patented I'd say the risk is pretty low.
Ye$$$ PRAN is a risky play but if decisions turn in favor of PRAN in Europe, this stock is headed much higher
Doesn't hurt that their balance sheet is favorable to PRAN ADR holders. Could see some dilution down the road but at much higher levels if everything goes as planned - added more on dips - staying interested - best wishe$$$!! Go PRANA€€€€$$$$
And TGA to follow-EMA, TGA Launch New 'Collaboration' to Accelerate Access for Orphan Medicines
Posted 07 April 2014
By Alexander Gaffney, RAC
EU and Australian regulators have announced that they will begin sharing information about orphan medicines in an attempt to accelerate approval for new drugs intended for rare diseases.
Orphan status in Europe is significant. From GK after the 2A trial - "in a manner also consistent with the new".."EMEA regulations that permit accelerated conditional marketing approval for treatments of seriously debilitating diseases such as Alzheimer's disease."
Although PBT2 is recommended for approval for HD with the European declarations relating to Alzheimer's I wonder if this would help and speed PBT2 to approval more than in the US since they are also more open to off-label use in Europe than in the US?
This is almost more cash than Prana has had at any time in the past.
Judging by the response of the market to Biogen results (and they are not great by any means) the extension results may provide an added boost to the SP. These are due likely June but maybe July.
You are correct this is a very good step forward for Prana. Options to advance in Europe for PBT2 if it gets held up by FDA. In a few weeks we should know the final decision from the European Commission.
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