Oh boy...Get ready...Stay tuned...ITS SPIRE EARNINGS REPORT SEASON!!!!!!!!! Last time they cancelled the conference call (or maybe the phone company shut off service for lack of payment). Now there are rumors (that I'm starting) that say this quarter's conference call will be made from the basement of Roger Little's home. That way, none of the investors will hear the 2 remaining employees in the background begging to be laid off like all of the others. Another rumor (that I'm also starting) says that the earnings report had to be re-done because a visitor had some change slide out of their pocket and into a chair in the lobby. Get it...the change had a "material impact" on earnings! HA!!!!! Somebody stop me!!!!!!!!!!!!
It seems to me that AEMD benefits when patients have a say in the devices that are used fore their treatment. Personally, if given the option of having the HP included in my treatment, I would not hesitate to include it.
Well FDA is beginning to look at including patient preferences. The FDA process is probably too slow for this to impact AEMD and the HP clearance, but then again...
Not a sign of recovery (Goodness, this one's been dead for a while, but the electrcial impilses kept it moving...). Watch for a sign announcing that the office furniture is for sale. There are probably some decent desks and chairs that will be available on the cheap!
I hate to complain. Especially when the share price rose 20+% today, but I was expecting more "pop". Does anybody else feel like the "big run up" that they were expecting after FDA approval of the IDE was barely a bump? Presumably, the next significant event will be the study results and then FDA approval to market the HP device. And that will take months...
There are some details to the Wyss approach that may cause problems if they were to ever seek FDA approval...their solution is a bead that is coated with a genetically engineered protein. That would probably be considered a combination product by FDA, but that combination is only part of the solution. After the coated beads attach themselves to the target cells, they must be removed by a magnetic filter.
In a regulatory environment where FDA challenged AEMD to show that the reduction in viral load that was observed in per-clinical trials correlated with cells collected in the HP filter (implying that the cells were removed but not through the actions of the HP???) the bar may be rather high for a combination product/medical device to acquire FDA approval without taking significant time. AEMD was in that position some years back (2008?).
While the future looks very bright for AEMD, we still have to wait a little longer, based on one of the lines from the "Thank you Shareholders" letter:
"We submitted an Investigational Device Exemption (IDE) to the FDA to request permission to initiate a clinical feasibility study HCV infected individuals who would be enrolled to receive Hemopurifier® therapy. We have since received comments and study design considerations back from FDA and are preparing a response that we hope will lead to the initiation of U.S. clinical studies."
We can only guess what those comments and study design considerations are, and hopefully they will be answered soon. FDA typically "stops the clock" after making such requests of a study sponsor and may or may not start the process over once a response is received.
Obviously Spire management has figured out the problem and implemented lasing resolution. The increase in stock price should be long-lasting...ooops, wait a minute!
I believe AEMD has a number of options here, but the most common is to secure FDA approval for one condition and then go back to FDA with a new IDE for the remaining conditions that would be treated (or at least a subset of them). This gets the revenue pipeline established and affords the company to get funding for broader studies.
If AEMD goes that route, the IDE would be approved within a month (barring questions from FDA or a flat-out rejection) for a particular condition and the ci]linical studies of safety and effectiveness (S&E) for that condition would be used to acquire FDA approval through PMA (180 days for FDA approval). Then, with revenue coming in on THAT condition, AEMD would be in a position to fund studies that would result in additional PMA's.
Another option would be to expand the study once the IDE was started, but this requires additional approvals and there is no "interim" milestone of demonstrating S&E nor the revenue that comes with that. AEMD's announcement of a limited study (10 subjects?) would indicate that they are looking for an immediate interim milestone.
FDA has provisions for approving different types of device changes through PMA supplements, etc. but I don't think they apply here because the clinical information changes for each new condition to be treated.
Again, just my opinion...
Again, just my opinion.
Sentiment: Strong Buy
The PR doesn't specify the date of the IDE filing, so we're left to figure that out ourselves. I can only speculate but in my experience with FDA, the filing date is closer to 14 DEC. keep in mind that FDA may request additional info and that would slow approval of Aethlon's application. But as someone else pointed out, the India testing lends credence to the effectiveness of the device itself. So long as AEMD did their homework in writing the application, they should not experience significant delays.
Just my opinion
Sentiment: Strong Buy
FROM FDA website:
"An IDE application is considered approved 30 days after it has been received by FDA, unless FDA otherwise informs the sponsor prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved. In cases of disapproval, a sponsor has the opportunity to respond to the deficiencies and/or to request a regulatory hearing under 21 CFR Part 16."
Sentiment: Strong Buy
I've been watching the FDA website pretty closely to see if any information on Aethlon, HP or the IDE are posted. When I saw the Press Release, I checked again and found an Establishment Registration for Aethlon with a "site last updated" date of 14DEC. I'm fairly certain that this Establishment Registration was not on the FDA site prior and it stands to reason that it would accompany an IDE filing.
Unless FDA has concerns/questions, an IDE application SHOULD be answered within 90 days (calendar). The Agency has been under pressure over the last few years to respond quickly to all such filings by device (and drug) manufacturers. Unless Aethlon has not done its homework (and assuming that the filing was made around 14DEC), it should be a "prosperous" Spring for us Longs...
Sentiment: Strong Buy
Maybe you know, does Extreme Value Stocks consider lack of revenue potential, declining markets, poor products, alienation of past customers, burgeoning debt or incredibly stupid management in their evaluations, or is it just a wild guess?
Does anybody know what happened when AEMD submitted their Hemopurifier IDE in 2007? Are we likely to wait another 5 years or is this time different?
It seems as though a lot of people have been waiting for this company to reach its potential for quite a while. Is there reason to believe that change is coming?
Hmmmm- if the share price is $0.55 now, what will it be in 5 quarters. Mr. Little Speedo has a better chance of winning an Ironman than he does of having a company at the end of 2013.
This one's done folks!
This thing should be traded on the Playschool Stock Exschange using Monopoly money! Stock Certificates would be written in crayon by kindergarten students who make them in their Arts and Crafts class. "O.K. children, after milk and cookies we need to make 2 more stock certificates for Mr. Little's company. Whoever does the best work in making the stock certificates will get a Gold Star for the day!!! Everybody be sure to wash your hands".