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This should be interesting. No news, no website updates, no India news, no Darpa news, no news at all. What's up? Any guesses?
Aethlon must be really busy because they don't even have time to update their website. How hard would it be to add the FDA IDE approval and new Darpa grant info?
We need an update from Aethlon. It's time to lay it all out, even with a shareholders letter. Maybe we will get that tomorrow.
The problem is lack of back to back news. Aethlon should have followed up with more detailed information, or Darpa, INDIA, etc. We will probably see more news Tuesday, but not enough to keep pushing us. It's back to a long waiting game. IMO.
It's all good. We will get the FDA IDE approval. It always turns into thinking the worst when there is long term silence. I'm also thinking next week and after the approval we can move on to something else to worry about. I'm also a believer that were getting more than we expected, so my bet is there will be a lot of happy shareholders real soon. :) IMO
My guess is that a representative from Aethlon is at the exosomes seminar at MD Anderson today.
http://www.ibmc.up.pt/events/seminars/power-small-micrornas-and-exosomes-cancer-biology
Ya, spoke to soon. Now it's slowly moving.
Yesterday .105 was fine, but today its lower and no one wants to play.
I can't believe no one is buying at .104 based on our volume yesterday. I would if I had the money. I was actually expecting a high volume today.
This is interesting. An exosomes seminar on the 14th at MD Anderson.
http://www.ibmc.up.pt/events/seminars/power-small-micrornas-and-exosomes-cancer-biology
Northern California
Lets hold the back flips until Vegas, so we have something to bet on. :)
http://www.marketwatch.com/story/a-new-approach-to-treating-cancer-2013-06-05
Why get news on cancer exosomes now when Aethlon is so close to Hep C IDE FDA possible approval. Shouldn't the Hep C IDE be more important now? IMO
Again he leaves it open for assumption. Yes, I may be reading way too far into this. In the last sentence of this paragraph why not say, "to include cancer in the near future after our Hep C IDE is approved." Either way I'm anticipating exosome studies quicker than we think. IMO
"It already has. Its called the Aethlon Hemopurifier®, which is a medical device we created to rapidly eliminate a broad spectrum of viral pathogens, including Hepatitis C, from the circulation of infected patients. As it turns out, infectious viruses and tumor-secreted exosomes share an evolutionary structure on their surface that helps to cloak them from the surveillance of the immune system. Because our Hemopurifier® targets this unique structure, we have the opportunity to leverage our infectious disease treatment experience and expand the utility of our device to include cancer."
Yet again JJ does not mention Hep C specifically to the IDE. How hard is it to place "Hep C" between "initiate and human" in the paragraph to make it completely clear. He leaves it up to assumptions. Hmm. IMO
"In the short term, our primary focus is to obtain FDA approval of an investigational device exemption or IDE that would allow us to initiate human feasibility studies of our Hemopurifier® in the United States. The clearance of our IDE is an instrumental step in executing our business plan and it would likely raise the stature of our endeavors within the medical community. Based on our interactions with the FDA, we are hopeful that our IDE will get cleared this month."
Lee, I agree that probably is going to happen. It sounds like Hep C only. What's good is that after the IDE approval it should be a lot easier to get approval on the others. I was just hoping that JJ included it (Broad Spectrum Capabilities) which would be a great press release.
Lee, I would agree, but in the Redchip interview (13:42)he talks about the IDE and hopefully having it by year end (True). What I found interesting is that he does not mention Hep C and states, "To get started here in the clinics." (Plural) Is Aethlon going to use multiple clinics just for Hep C testing?
I know I've beat this into the dirt, but I still have hopes that JJ added the collection of exosomes into the IDE submittal to the FDA. IMO it only makes sense. All JJ would have to do is add a test location and the rest is the same as far as collecting (I believe). The Hemopurifier® collects and can not decipher between these collected particles as indicated below. Plus, I find it suspicious that exosomes have been in the spotlight with Aethlon, especially when JJ said he was going to ammend the IDE to include exosomes, but now its silent and in waiting for the Hep C IDE approval. We could get more news than we think, and why wait another year or so, when the hemopurifier collects them anyway. again all IMO.
"The Aethlon Hemopurifier® consists of the lectin Galanthus nivalis agglutinin (GNA) immobilized in the outer-capillary space of a plasma membrane device that is compatible for use with standard CRRT and dialysis units. GNA-based capture is mediated by unique high mannose signatures abundant on the surface of cancer-secreted exosomes as well as glycoproteins that reside on the outer membrane of infectious viral pathogens."
As we move into another week and month I find it interesting that Aethlon has nothing to report, especially in regards to the sepsis grant, exosome stuff, or even India info. Aethlon hasn't even updated their website in regards to the news of the Sepsis grant and partnership. How hard can that be. Again, my only thought is Aethlon is holding back everything until the FDA IDE is announced. With that said, they can't wait too long, so we should be getting something real soon. :)
I am also guessing that this next resubmission will not take as long to review, so with saying, I would expect an answer next week if Aethlon submitted based on the timeline noted by JJ. Earlier Aethlon resubmitted on March 25th and we received news by Aethlon on May 7th, approx. a month + later. I would expect this resubmission to take a little less time, so my guess is next week, but I know, we're dealing with the FDA. IMO.
This is just my optimism, but I'm guessing Aethlon is holding back on any PR's until the FDA news. I find it hard to believe that Aethlon would hold back any PR's of any kind for another month, so I hoping for any day vs. next month.
We are one more week closer to FDA approval for studies. That is good news entering a new week :)
It's funny how silence and waiting changes behavior and thoughts. Lets stick with what we know and not assume. It's obvious that JJ is waiting for the FDA news. If they were worried we would be getting a lot of survival trash PR. We've got this guys, lets just wait the storm out and eventually we will see sunshine... :) It's all good....IMO
Based on the Hemopurifier being able to collect high-mannose glycoproteins on their outer surfaces, I would hope that Aethlon added the collection of exosomes to their FDA IDE submittal. There is a lot on the line currently within cancer care and Aethlon can not even use Her2some without the an FDA approval for exosomes. I'm hoping its a surprise and that JJ added it and that's what really causing our delay.... I have very high hopes.
"In the case of the Aethlon Hemopurifier®, we have created a therapeutic filtration device that selectively captures a broad-spectrum of disease promoting particles from circulation without eliminating blood components required for health. However, instead of immobilizing an antibody or agent that specifically binds to a single pathogen, we made the bold decision to deploy the capabilities of a lectin affinity agent that binds to a unique structure evolved and shared by viruses and cancer as a survival mechanism that allows disease progression to continue below the surveillance of the immune system"
This is where I am stuck...basically one lectin affinity agent that binds to unique structures shared by all..If so, this is big, especially when it comes to FDA IDE approval. It will make it a lot easier to obtain FDA approval for others besides Hep C. I actually think they should have already placed it in the IDE, based on it having broad-spectrum capabilities and already collects them.
Sorry that I keep talking about the same thing, but I think this is huge and will help with our current IDE, or future ones. I'm done pushing my point. lets hope approval comes soon :)
That sounds more understandable, however, Aethlon does not discuss (That I know of) that they use different affinity agents within the hemopurifier for specific viruses or exosomes. That's what is so interesting to me.
"The Aethlon ADAPT™ system is an adaptive dialysis-like affinity platform technology that provides the foundation for an entirely new class of therapeutics that target the selective clearance of harmful agents from the entire circulatory system. Therapies that evolve from the Aethlon ADAPT™ system overcome the historic limitation of extracorporeal strategies that indiscriminately adsorb or remove particles solely by molecule size. In function, our device platform allows the immobilization of single or multiple affinity drug agents in the outer-capillary space of plasma membrane technologies as a means to provide rapid real-time clearance of corresponding targets without adding drug toxicity or interaction risks to established therapies."
From what I gather from the above statement is that the ADAPT system is basically a way that drug companies can use their drug agents within the hemopurifier to reduce or limit toxicity to the patient. The ADAPT system is soly a holding mechanism for a particular drug and has nothing to do with the actual Hemopurifier affinity agent that obsorbs the virus or exosomes etc. Basically, the blood flows through obtaining a combination of the drug agent and the virus collection from the Hemopurifier affinity agent. Again I may be wrong here.
"The Aethlon Hemopurifier® is a first-in-class medical device with broad-spectrum capabilities against viral pathogens, including the human immunodeficiency virus (HIV), hepatitis C virus (HCV) and numerous bioterror and pandemic threats. Human studies have demonstrated the Hemopurifier® to be safe and provide average viral load reductions of greater than 50% during four-hour treatment periods in both HCV and HIV infected individuals without the administration of antiviral drugs. The device is currently the subject of a human clinical study in India to evaluate its ability to accelerate viral load depletion when utilized in combination with HCV standard of care drug therapy. An investigational device exemption (IDE) to initiate clinical studies in the United States is pending with The Food and Drug Administration (FDA).
In vitro studies have also documented that the Hemopurifier® captures exosomes underlying cancer, including colorectal, lymphoma, melanoma, ovarian, and breast cancer."
As far as the Hemopurifier itself, as listed above, they do not discuss the use of additional affinity agent for specific viruses and exosomes. For example the last pharagraph above they do not say that a different agent is used within the hemoopurifier for exosomes. You would think that Aethlon would specify that the Hemopurifier is just a collection capsule where different affinity agents are used to capture an assortment of viruses and exosomes. It sounds, based on my reading that one lactin affinity agent does it all...Again, "broad-spectrum capabilities against viral pathogens, including the human immunodeficiency virus (HIV), hepatitis C virus (HCV) and numerous bioterror and pandemic threats." I may be missing the big picture, please let me know..
The reason this is so important is that if Aethlon has one lactin affinity agent that collects "high-mannose glycoproteins on their surfaces" it would be a catch-all-and-sort later issue.
"To define the glycoprotein signatures associated with specific disease conditions, researchers have applied panels of carbohydrate-binding proteins (lectins) to determine the relative compositions of specific carbohydrate residues in cellular material. Extrapolating on the use lectins as research reagents for biomarker discovery, our device platform leverages the specificity of lectins for glycoprotein-coated particles for therapeutic affinity capture."
The above pharagraph sounds to me that after collection researchers can use specific lectins to determine the origin of the cellular material. I believe this is how Aethlon was able to count the amount of the Hep C virus collected, based on its signature. This is also why they invented ELLSA to study specific signatures that were collected within the hemopurifier? I guess what I'm trying to say is why invent ELLSA if there are specific agents they can use within the hemopurifier for identifying specific exosomes? collect all-sort-all later?
Again, please help me out. This is just me trying to figure it all out. Thanks for all your help...
PhilB, If that was the case then I would assume we would have different labelled Hemopurifiers showing different purposes. IMO
"We made the bold decision to deploy the capabilities of a lectin affinity agent that binds to a unique structure evolved and shared by viruses and cancer as a survival mechanism that allows disease progression to continue below the surveillance of the immune system."
Can someone please assist with my confusion here? As I mentioned earlier Aethlon has only one Hemopurifier with one specific lectin affinity agent that binds to viruses and cancer related to Glycoprotein-coated particles. I believe only one agent, but if they have specific agents please let me know because that's where I am confused.
So my question (if only on agent) is, if this one lectin affinity agent captures all Glycoprotein-coated particles, such as Hep C, HIV, Exosomes, etc.(There's probably more)then how can they make it specific? Meaning, even though they are collecting Hep C particles the lectin affinity agent is collecting all glycoprotein-coated particles, besides just Hep C. This is how it appears to me anyway. Again unless I've read wrong and they have specific agents for different viruses and cancer.
So another question based on one affinity agent that binds to glycoprotei-coated particles. When Aethlon is conducting tests and can determine how much and what type of Glycoprotein (Virus-Cancer) do they just ignore the possible other types of glycoprotein-coated particles that are collected and not related soly to the hep C virus?
Again I'm probably wrong, but very confused.
I heard JJ mention some time back that he was planning on adding exosomes to the Hep C IDE FDA submittal. With that said, I also understand that recently there have been no discussion regarding the addition of Exosomes to the IDE. Based on the capabilities of the Hemopurifier how difficult would it really be? Below is from a recent PR, which sounds to me the protocals would be relatively similar, but I may be well off. I'm probably asking for too much, but would'nt it be nice to hear "FDA IDE approval for Hep C and cancer exosomes"
PR dated Feb. 28th
Aethlon Medical (AEMD) Note: Multiple Shots on Goal - A Therapeutic Strategy to Address Infectious Disease & Cancer
"In the case of the Aethlon Hemopurifier®, we have created a therapeutic filtration device that selectively captures a broad-spectrum of disease promoting particles from circulation without eliminating blood components required for health. However, instead of immobilizing an antibody or agent that specifically binds to a single pathogen, we made the bold decision to deploy the capabilities of a lectin affinity agent that binds to a unique structure evolved and shared by viruses and cancer as a survival mechanism that allows disease progression to continue below the surveillance of the immune system."
"Of relevance to our Hemopurifier® is the observation that critical disease-mediating particles in many viral infections and cancer display high-mannose glycoproteins on their surfaces. These surface features arise during the process of glycosylation, whereby carbohydrate residues such as mannose are tagged onto proteins to ensure proper protein assembly and function in healthy cells. Not surprisingly, this process becomes perturbed in several disease conditions, thereby changing the biologic functions of proteins. To define the glycoprotein signatures associated with specific disease conditions, researchers have applied panels of carbohydrate-binding proteins (lectins) to determine the relative compositions of specific carbohydrate residues in cellular material. Extrapolating on the use lectins as research reagents for biomarker discovery, our device platform leverages the specificity of lectins for glycoprotein-coated particles for therapeutic affinity capture."
I only took portions from the article, but if Aethlon focuses on Glycoprotein-coated particles then would'nt it be a give-all for viruses and exosomes? and would'nt the procedures be similar?
You know what I like? Everyone seems positive. Love it..... And talk to you guys after our FDA approval. So nice it hear cheers...., we will get it, it's just patience....see you all soon... :)
"In this regard, FDA withheld clearance of our recently amended IDE based on a single information deficiency that was deemed a safety concern. Specifically, FDA has requested that we detail our training and monitoring procedures related to heparinization, which is the primary anticoagulant utilized in dialysis and other extracorporeal therapies, including our Hemopurifier®."
It's all good. No one would have expected this request because dialysis already does this. This is obviously a stall technique. Put it in writing, submit, and its all good. This is actually great news. We just have to wait a few more weeks. I bet the volume rises now with upcoming easy approval. Again., great news. Great news guys...
Little things are tell-tell signs? Isn't a little weird that a small company hasn't updated its website? They could update the new Darpa grant info,(come on, 22 million? With partnership) plus all that cool exosome info, but everything's on hold. Why? If I was grabbing for straws I'd do anything, but these guys seem way too confident. Ummm, they seem not to be too worried, or they forgot they have a website.... They are definitely very busy to worry about the small stuff. :) IMO
Phil, it will come. Thanks for trying, but we shareholders are not in the loop until PR time. I'm hoping tomorrow.
It's all good. This will be a great week.....FDA is in the bag... Aethlon worked too hard to mess this up. That's why India news stopped. They have worked real hard and it will pay off. I can't see one reason why the FDA would deny Aethlon. They have done everything asked, and lets not blame the drug companies. We are past that. Actually, Aethlon is any drug companies best friend at this point in the hep, sepsis, cancer, HIV world. Lets look at the positives. It all about advantage. Advantage over the other drug company...Aethlon has the market, and I won't eat these words..... :) I won't eat these words.... It just takes time and the silence is are friend just like we waited for the Darpa grant..., relax, they know what their doing. We are just on the sidelines guessing what may happen next......trust trust trust.....again IMO
Thanks for taking the time with the FDA. I guess "Closed" sounds better then "Denied" If it's closed then we should be hearing an answer very soon.
Well there hasn't been any fluff PR's in the mean time, which I would expect would happen if we didn't get the approval. My feeling is good. We waited a long time for the grant PR, with no fluff, so silence is are friend right now. IMO
Question? I understand that the FDA must respond during the first submission within 30 days, but what about a re-submission/response? is there a guideline for that? Everyone is under this 30 day timeline, but is it truly 30 days during a resubmission? I'm not so sure. It sounds to me that if there are questions and responses then it's an open time line. Please fill me in here....
Either way the FDA can not deny us because there may be something better out there. Hold on we're going to get approval. Its just like the Darpa grant. All Aethlon is doing is getting everything set up for a great PR. Enjoy the silence because that means we are still in the running. Stay positive.....
It's all good...be patient, it will come.... :)
The odds are in our favor. Relax, within a few days or so we will be moving on to another milestone. I M O, FDA is in the bag....we have all been waiting for these times, so I say enjoy, currently we have no real reason not to....great times guys..... :)