Acusphere, Inc.
(Public, OTC:ACUS)
It is important to note that as with all FDA pending approvals, there is a tremendous amount of uncertainty. However, just remember that amongst uncertainty lies opportunity!
That being said, continuing with the FDA journey to riches I have chosen ACUS as my next prime target. I see alot of benefit and potential in this company, not only from its currently cheap PPS, but also from the vast potential market. The time is now to load up on this company (if you haven’t already done so) while the price is still at a discount. I expect big things to come within the next two weeks, so fasten your seat belts and let your portfolio fly.
About: Acusphere, Inc. is a specialty pharmaceutical company that develops drugs and formulations of existing drugs using its porous microparticle technology. This technology enables the Company to control the size and porosity of particles, including nanoparticles and microparticles, so that the particles can be customized to address the delivery needs of a variety of drugs.
FDA News: Amended NDA for Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension as a cardiac imaging agent for the detection of coronary artery disease. Amended indication would be limited to subsets of patients undergoing pharmacologic stress techniques compared to original request for more widespread use with an expected PDUFA decision date of 5/31/09.
Background: Approximately 16.0 million people in the United States suffer from coronary artery disease (CAD), and it is the leading cause of death in the United States. [American Heart Association, Heart Disease and Stroke Statistics, 2007]. CAD is characterized by the accumulation of plaque and can reduce blood flow in the heart muscle often leading to recurrent chest pain, heart attack, or death. Early identification and intervention are crucial.
A key indicator of the presence of CAD is blood flow (perfusion) deficits in the heart muscle (myocardium). The current standard for detecting perfusion deficits is through conducting a Nuclear SPECT Stress Test (Nuclear Stress Test) which is expensive, time consuming and exposes patients and providers to radiation.
We are developing Imagify™ to address a clinical need for an effective and rapid non-invasive means to identify the presence of CAD before a patient has an event without the use of radiation.
Imagify is an ultrasound imaging agent comprised of perflubutane gas in a synthetic biodegradable microsphere whose primary components are already used in other approved pharmacologic products such as surgical sutures. Imagify is administered intravenously and is intended to allow visualization of perfusion deficits in the myocardium in addition to movement of the muscular walls of the heart.
Potential benefits of cardiac ultrasound enhanced with a perfusion imaging agent include the following:
Clinical Information
- Cardiac stress ultrasound with a perfusion imaging agent has the potential to provide information on both myocardial perfusion and real-time wall motion simultaneously.
- Cardiac stress ultrasound has the potential to provide real-time information without requiring post-processing and analysis.
No Radioactivity
- Ultrasound contrast agents usually do not require special licensing for storage and handling, have a long shelf life, and are convenient to use and store.
- Nuclear stress tests use radioactive materials that create additional costs due to preparation, storage and disposal requirements.
Less Time
- Nuclear stress tests typically take five hours, while ultrasound procedures typically take less than one hour.
Lower Expense
- The cost of performing an ultrasound imaging procedure using ultrasound with a perfusion contrast agent is expected to be significantly less than for a nuclear stress test.
Stay tuned as next week I will release news on a company with treatment of chronic heart failure which has amassed a very high probability of FDA approval based on preliminary tests and studies.
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By reading StocksHaven Investments you agree not to hold Michael Vlaicu accountable for any transactions or decisions you make. It is up to you to do your own due diligence.
Hmm.. the only problem is that I hate trading OTC stocks.. there always seems to be some fraudulent activity going on.
I hear that!!
I’ve become extremely gun shy to OTC stocks.
Due your DD on the company and conduct tons of your own research first, as always.
Jumped on the boat at .485. Hope I didn’t miss out.
@David, I am sure it has a bit more to go before it reaches the ceiling pre-FDA decision.
Take a look into ABIO as well.
Appreciate the advice! Buying a few more shares of ACUS today. It got beat down a little yesterday, so seems like a good buying opportunity.
Hi Michael,
Thanks for the excellent conference call that you had conducted with HEB CEO. I am sure it has really opened up lot of peoples’ mind on HEB and its future proespects and have given an insight on the chances of Ampligen being approved. Having said that, why don’t you do the same thing with an Acusphere official and ask them about their prospect and what changes did they make on their product after the initial decline from FDA and what are the chances of approval this time.
Really appreciate your help and hardwork.
-Nash
Hi Michael, I took your advice and purchased 20000 shrs. @ $.41. The next day it dropped big time to .23 a shr.It did rebound to approx. .32 quickly.I was wondering if you had any rational for the big decrease in price that occured so abruptly?
@Steve, it is under my impression that a lot of the investors in ACUS have now switched over to HEB. However, the FDA decision is what will most impact both of these stocks.
Thanks for the ACUS summary & advice, I’ll have to look into it.
Some questions on the FDA’s role: Have they judged imaging-related substances in the past? How will they be judging Imagify? Do they have the capacity & resources?
One concern is that even if the science behind ACUS’ products is sound, it doesn’t seem like your standard FDA approval. & while ACUS’ products sound like they could legitimately reduce costs, I’m not sure cost-saving products are as highly valued by the FDA, or by a fractionated over-regulated healthcare system which sometimes favors the more expensive solution.
But I’m still quite interested. Any thoughts?
Hi Michael,
thanks for Heb, and Ctic, i win a lot of money. You’re my god!
I bought 40.000 shares at 0,30 of ACUS.
Sell this shares or Hold? What happen with Acus? FDA is coming?
King regards.
Oscar
@Oscar,
Delayed for a long time.
What does mean “delayed for a long time” ? one year, two years, five years? Thank you