The symbis is not close to FDA approval. They said they were looking to install the SYMBIS System in two more hospitals in the USA in addition to the one in Canada which has been their only installation. They said they needed the additional installations to generate more data for the FDA. In my opinion, the soonest they will get FDA approval is the second half of 2014 or perhaps the first half of 2015 for the SYMBIS System.
The CT Scanner is expected to get FDA approval this quarter (Q2-2013). That could add to their revenues for this year. This is really a good time for Hospitals to be spending money for their infrastructure needs given that interest rates are so low. I am hoping that they can meet or exceed their revenue guidance for this year so that they can get closer to breakeven.
They may not have to sell any more shares to raise capital if they have good results in the two trials they have going. A deal with a big Pharma may give them enough up front (say $350 million) which would be enough to carry them through to approval.
My guess is that they started the HD study in order to avoid a "squeeze" from a Big Pharma when it came down to making a deal after good AD results. Big Pharma knows that PRAN does not have the resources (money) to do a phase 3 for AD and will squeeze them HARD in a deal for Pbt2. However, if they succeed in an HD trial, they can possibly do a phase 3 for HD and get a quick FDA approval as an orphan indication and make enough money on the HD drug to put PRAN in a strong negotiating position to deal for the AD drug.
The failure of Gammagard puts the nail in the coffin for the antibody approach to clearing the brain of A-beta and Tau (IMHO). This gives me additional confidence in PRAN's approach which is attacking the cause of the A-Beta and Tau build-up. It sure looks (to me) like PRAN will show statistical significance in the AD trial. However, I don't have the same level of confidence in the HD trial.
Thanks goutah3006! I appreciate your detailed answer. I made my first purchase of PRAN early this year and I have been adding a little at a time as funds permit. I was not aware that they reported on a six month basis. My gut feel says they will be successful in their AD Trial. Everything I have read leads me to believe that. I believe that Pbt2 works at least as well as Aricept and while Aricept is not a disease modifying drug, I think Pbt2 is. Thanks again!
They may give an update on the trial, re-affirm timelines, announce participation in a conference or two, give a good picture of their cash position and spend rate, give some guidance,...etc.
About the disease
Alzheimer's is one of the most common forms of dementia. The death of brain cells in AD has been linked to two proteins called beta-amyloid and tau. Beta-amyloid forms the plaques and tau forms the tangles seen under the microscope in the brains of patients with AD. The plaques and tangles distinguish AD from other types of dementia. AD symptoms include debilitating confusion, memory loss, irritability, and anxiety. The disease is eventually fatal.
The first new approach to fight AD comes from Dr. Rudy Tanzi, the Joseph P. and Rose F. Kennedy professor of neurology at Harvard Medical School. He was among the scientists who discovered the first AD genes back in the 1980s. Now he's helping to map the rest of the genes linked to AD.
Tanzi also helped create PBT2, a drug that's now in phase 2 clinical trials in Australia. Unlike the recently failed drugs, which use antibodies to attack beta-amyloid, PBT2 takes another approach. Certain metals in the brain (copper and zinc) help drive production of the plaques and tangles. PBT2 prevents this from happening. "It takes the metal away from the amyloid protein so it can't form plaques. It removes metal that was trapped and makes it available again for dozens of brain functions like gene activity and antioxidant health. PBT2 also keeps tangles from forming. And finally, it induces new neurons to grow in the hippocampus, which should improve executive function," says Dr. Tanzi.
Results from the initial animal trial and the first two clinical trials were encouraging, with no significant side effects. "They've only been small trials, with less than 100 people, but we've seen significant improvement in executive function in just 12 weeks," he says. "It remains to be seen how it works on overall memory."
Scientists are now testing PBT2 in combination with imaging techniques to get a visual picture of how effective the drug is in removing amyloid plaques. If all goes well, the drug will progress to larger
I hope it is one of your top picks for 2013 as well ;-^). I think IMRS has a great long term future and a lot of catalysts this year starting with the present quarter. I only have two other TOP PICKs. They are PRAN which has a Huntington's Disease phase 2 trial with results due in October and an Alzheimer's Disease phase 2 trial with results due in January. They have a very unique mode of action for their drug and they are the only ones with this approach which came out of the labs of DR. Rudolf Tanzi who is a professor at Harvard Medical School. PRAN has a market capitalization of less than $100 million. My second TOP PICK is ARNA. Do your own due diligence. IMHO all three will pay off big.
The market capitalization for IMRS is only $150 million. IMRS has a lot of investment in its product development and it is at the leading edge of technology. The best hospitals are accepting their leading edge technology and installing their systems. As their installed base increases, it will accelerate their sales growth as they add to their family of products which work together to give the hospitals a competitive edge in attracting patients. Their Ceiling Mounted CT Scan System is expected to get FDA clearance this quarter and their MR guided brachytherapy system is perhaps getting the FDA clearance next quarter. I believe IMRS is flying under the radar of many big investors/fund managers. IMHO this price is a gift to the retailers like us.
From a TA analysis standpoint, IMRS flew through the $3.00 mark on its way to a recent high of $3.30. It has now retraced back to $3 from where it is ready to resume its move up. The last financing was done at $3.50 per share in March when they raised about $20 million. It's great when we retailers can buy at a discount to the big guys.
Anyone know about Eisai's trial drug Ed609 for Alzheimers and how it works? See Following:
This time, GE Healthcare will ally with Eisai, a Japanese pharmaceutical giant. Eisai is revving up a Phase I clinical trial for Ed609, an amyloid inhibitor and hoped-for Alzheimer's treatment. To help select patients for a trial, Eisai will use GE's flutemetamol, a PET imaging agent designed to help diagnose Alzheimer's disease by detecting beta amyloid buildup in the brain.
There were two trades within 3 minutes of the close for over 30,000 shares (considered after hours) which brought the shares up to $2.775 after hours. The insider transactions are not listed for some reason. However, their financing in January was at $3.50 a share and this should be a good growth year for their sales. Along with the expected FDA approval for their Ceiling Mounted CT Scan System this quarter, we may be at the lows for the stock price. At this point the risk has been reduced quite a bit and to me it looks like a good investment. They should be attracting a lot of new investors this year. IMHO
They have a leading edge product and much more on the way!