Ampio Pharmaceuticals' Pipeline Doesn't Look Good [View article]
Adam,
Right now you are probably amazed at how quickly traders acted on your article that was extremely misleading and slanted to favor your short position and any other incentives you may have.
First, you mislead and misinform readers about the importance of a Pre IND meeting. Fact: The FDA has a very limited number of experts and will absolutely not commit them to a Pre IND meeting unless they are compelled by a strong belief that the drug has strong promise with both safety and efficacy. Fact: Ampio has had 3 successful meetings with 18 experts present at each meeting. Fact: This is a strong indication that the FDA is favorably impressed with results from prior trials that must be submitted to them 4 weeks prior to the meeting date. Pre IND meetings can be mundane, but not if 18 experts are present as in the case of Ampion, Optina and Zertane.
Second, Zertane's efficacy, just like Ampion and Optina is undeniable once one actually reads the results but so far as patients buying Tramadol and trying to cut it up into small pieces and taking it for a cheap drug for PE is not very likely. Besides, it is impossible to get the right dose. Sales of Zertane are expected to be quite large.
Martin Shkreli, if he made this statement as you indicated, is not correct in his projections because he has not taken into consideration the massive savings by being allowed the 505 (B) 2 pathway where safety data from the previous trials is allowed to be used thereby saving millions of dollars and years of time and also greatly reducing risk of failure. Estimates for all three trials by the company were recently announced to be adequately supported by the existing cash in the bank today. And that amount is far below your estimate.
Ampio is having no difficulty enrolling patients for the upcoming US trials. And to repeat, the reason Zertane was returned to Ampio was because Valeant made a blanket corporate decision to suspend all R&D projectss of which Zertane was one. Unfortunately for Valeant, they returned Zertane to Ampio before they ever examined the amazing data from the clinical trials.
So far as men and women desiring the male to use the drug, you have to be kidding . . . Zertane and especially Zertane ED will be the SuperSex drug of the deade.
You obviously have not been following the efficacy reports on Ampion or you would know that they are off the charts. Go to TraderInvestorAlert.com and read the interview about it. I think you will be covering your shorts very quickly and even reversing your position because Ampion is definitely going to be a huge blockbuster anti-inflammatory and soon.
The same holds true for Optina. The FDA was convinced by prior trial data that the efficacy and the efficacy warranted their assembling 18 of their top experts to provide guidance for a highly promising phase IIB trial that has the potential to roll into a pivotal phase III.
When I read the rest of your article it makes me realize you are just spewing senseless derogatory comments to enrich your short position and any other payment you are probably getting.
5 Surprising Facts About Hyperinflation [View article]
Interesting and good points but how is this going to impact inflation and the price of gold. Right now it seems like the teeter totter is stuck and nothing is happening. Is it possible gold is about to crash? Or is it likely that gold is about to rip to new highs?
Wish I had a crystal ball.
I do know an exceptionally undervalued stock that is cheap by any measurement and that I believe is going to be a huge winner for the next few years . . . It's not gold, but it might perform better than anything else . . . Ampio Pharmaceuticals AMPE
Regeneron's Success Isn't Limited To Eylea [View article]
Ampio's Optina™ is a pill rather than an injection on the eye (ouch!!), it is going t be much cheaper, it has no observed side effects and it has shown not only to reduce retinal swelling, but to improve vision greatly.
The data was so compelling from their last trial that the FDA granted guidance for a phase IIB trial that can be a pivotal trial and be rolled into a phase III.
Optina™ will overtake both Lucentis and Eylea. And it will most likely be approved for other indications such as diabetic nephropathy.
Ampio Unveils Revolutionary Medical Diagnostic [View article]
Yes, there are many Pre IND meetings requested every year but very, very few actually get scheduled. You will know if it is successful if the FDA is convinced by your data and scientist, if they actually hold the meeting and if they actually provide guidance for your phase III trial.
Here is my response to bio.bobby that will address your points...
bio.bobby, You are only partially correct but in a misleading way. It is a simple matter to request a Pre IND meeting and many are filed and requested every year but in order to actually have one scheduled, previous trial data better be compelling to the FDA or they will continue to ask for more information until they are satisfied or until you give up. The FDA does not routinely schedule Pre IND meetings unless they are reasonably comfortable with the prior safety and efficacy data and they also take a close look a the scientist.
If a meeting actually materializes, it turns out to be a vetting of the drugs performance and the scientist.
This is why you will see so few announcements of successful Pre IND meetings. Many are filed. Few are scheduled. Big difference!
If you have ever filed for one and actually gone through the process you would know that.
Ampio Unveils Revolutionary Medical Diagnostic [View article]
bio.bobby,
You are only partially correct but in a misleading way. It is a simple matter to request a Pre IND meeting and many are filed and requested every year but in order to actually have one scheduled, previous trial data better be compelling to the FDA or they will continue to ask for more information until they are satisfied or until you give up. The FDA does not routinely schedule Pre IND meetings unless they are reasonably comfortable with the prior safety and efficacy data and they also take a close look a the scientist.
If a meeting actually materializes, it turns out to be a vetting of the drugs performance and the scientist.
This is why you will see so few announcements of successful Pre IND meetings. Many are filed. Few are scheduled. Big difference!
If you have ever filed for one and actually gone through the process you would know that.
Ampio Unveils Revolutionary Medical Diagnostic [View article]
We are not talking IND's but rather Pre IND meetings. The Pre IND meeting not only vets the drug and the scientist, but if the FDA buys off on prior trial data, they grant guidance for the phase III that can save a lot of time, money and risk. Success is known by the guidance the FDA offers, IF THEY GET THAT FAR!
Pre IND meetings with the FDA are exceptionally valuable but extremely difficult to obtain. Before the FDA will commit to a Pre IND meeting, they require compelling safety and efficacy data from previous trials and compelling information about the scientists developing the drug.
The FDA typically has a staff of anywhere from 12 to 20 highly trained specialists reviewing this information and if they decide to set a meeting most of them will be present. At the point of the actual Pre IND meeting, the FDA has already seriously vetted the drug and the scientist or they would not allocate their time and their experts unless they were compelled by strong data from prior trials and confidence in the scientist developing the drug.
Pre IND meetings are little understood even by institutional investors, but one with successful FDA guidance can offer a high level of confidence to investors because of the intense vetting by the FDA’s large panel of experts.
A Pre IND meeting can result in failure or in profound benefits to the applicant such as a decision as to whether or not the FDA will accept safety data from previous trials that could result in very large time, cost and risk savings. If permitted, this 505(b)2 pathway allows use of the safety data from previous trials.
Another potential benefit to the applicant is that if the FDA is convinced the drug may be helpful to additional indications beyond the one the trial is designed for, they may allow the applicant to include those patients in the trial and if efficacy is demonstrated they may allow the drug to be labeled as being beneficial to those other indications. That could greatly expand the market for the drug in trial.
Ampio Unveils Revolutionary Medical Diagnostic [View article]
Also, Dr. Bar-Or is working with methylphenidates and is going to have some very big surprises in the not too distant future. These will not be repurposed drugs or biologics but the company has the best track record of getting through the FDA process in a timely and cost-effective manner. They already set a record by holding three Pre IND meetings with the FDA this year. Big pharma can't even do that.
Ampio Unveils Revolutionary Medical Diagnostic [View article]
Raja,
Thank you for your comment. Unfortunately his comments have had a negative impact on the shares and it is surprising to me that investors including Adam don't understand what having a successful Pre IND meeting with the FDA means. They are very difficult meetings to schedule and the FDA demands compelling data from prior trials and about the caliber of the scientists before they meet. This meeting is a very strong validation of the drug and the FDA's confidence to move forward.
Anyhow, you are right and the record will be set straight soon.
A Valuation Model For Arena's Belviq [View article]
Peter,
I wish you well. Diet and exercise are the only answer and the FDA and all health institutions know it and tell us that but very few people have the awareness that it takes to make the change to really see.
Just take a look at a healthy person who eats healthy food and who exercises. ONly 4 years ago I was obese, had extremely high blood pressure, extremely high blood sugar and was borderline diabetic, parkinsons dystonia, spiked PSA, disabling arthritis in my hands and not feeling very good. I was very close to death.
I changed my doet and at 70 years old I am lean and the strongest I have been in 30 years, no diseases remain, no medications, none, blood pressure of 110 over 65, resting pulse rate of 60, enough energy for 5 teenagers and I my mind is the sharpest it has ever been.
Life is amazing when you feel good the way we are all meant to.
I would be happy to share my know;edge with you.
Today, I am working with the world's leading nutritionist, Dr. Joel Fuhrmanto bering the most powerful all natural foods to your table that taste incredible.
Ampio Pharmaceuticals' Pipeline Doesn't Look Good [View article]
Right now you are probably amazed at how quickly traders acted on your article that was extremely misleading and slanted to favor your short position and any other incentives you may have.
First, you mislead and misinform readers about the importance of a Pre IND meeting. Fact: The FDA has a very limited number of experts and will absolutely not commit them to a Pre IND meeting unless they are compelled by a strong belief that the drug has strong promise with both safety and efficacy. Fact: Ampio has had 3 successful meetings with 18 experts present at each meeting. Fact: This is a strong indication that the FDA is favorably impressed with results from prior trials that must be submitted to them 4 weeks prior to the meeting date. Pre IND meetings can be mundane, but not if 18 experts are present as in the case of Ampion, Optina and Zertane.
Second, Zertane's efficacy, just like Ampion and Optina is undeniable once one actually reads the results but so far as patients buying Tramadol and trying to cut it up into small pieces and taking it for a cheap drug for PE is not very likely. Besides, it is impossible to get the right dose. Sales of Zertane are expected to be quite large.
Martin Shkreli, if he made this statement as you indicated, is not correct in his projections because he has not taken into consideration the massive savings by being allowed the 505 (B) 2 pathway where safety data from the previous trials is allowed to be used thereby saving millions of dollars and years of time and also greatly reducing risk of failure. Estimates for all three trials by the company were recently announced to be adequately supported by the existing cash in the bank today. And that amount is far below your estimate.
Ampio is having no difficulty enrolling patients for the upcoming US trials. And to repeat, the reason Zertane was returned to Ampio was because Valeant made a blanket corporate decision to suspend all R&D projectss of which Zertane was one. Unfortunately for Valeant, they returned Zertane to Ampio before they ever examined the amazing data from the clinical trials.
So far as men and women desiring the male to use the drug, you have to be kidding . . . Zertane and especially Zertane ED will be the SuperSex drug of the deade.
You obviously have not been following the efficacy reports on Ampion or you would know that they are off the charts. Go to TraderInvestorAlert.com and read the interview about it. I think you will be covering your shorts very quickly and even reversing your position because Ampion is definitely going to be a huge blockbuster anti-inflammatory and soon.
The same holds true for Optina. The FDA was convinced by prior trial data that the efficacy and the efficacy warranted their assembling 18 of their top experts to provide guidance for a highly promising phase IIB trial that has the potential to roll into a pivotal phase III.
When I read the rest of your article it makes me realize you are just spewing senseless derogatory comments to enrich your short position and any other payment you are probably getting.
Good luck to you and those who follow you.
5 Surprising Facts About Hyperinflation [View article]
Wish I had a crystal ball.
I do know an exceptionally undervalued stock that is cheap by any measurement and that I believe is going to be a huge winner for the next few years . . . It's not gold, but it might perform better than anything else . . . Ampio Pharmaceuticals AMPE
5 Surprising Facts About Hyperinflation [View article]
Regeneron's Success Isn't Limited To Eylea [View article]
The data was so compelling from their last trial that the FDA granted guidance for a phase IIB trial that can be a pivotal trial and be rolled into a phase III.
Optina™ will overtake both Lucentis and Eylea. And it will most likely be approved for other indications such as diabetic nephropathy.
Ampio Unveils Revolutionary Medical Diagnostic [View article]
these are private filing but are usually announced by the company filing them
510 k submissions are usually very quick approval times
Ampio Unveils Revolutionary Medical Diagnostic [View article]
Here is my response to bio.bobby that will address your points...
bio.bobby,
You are only partially correct but in a misleading way. It is a simple matter to request a Pre IND meeting and many are filed and requested every year but in order to actually have one scheduled, previous trial data better be compelling to the FDA or they will continue to ask for more information until they are satisfied or until you give up. The FDA does not routinely schedule Pre IND meetings unless they are reasonably comfortable with the prior safety and efficacy data and they also take a close look a the scientist.
If a meeting actually materializes, it turns out to be a vetting of the drugs performance and the scientist.
This is why you will see so few announcements of successful Pre IND meetings. Many are filed. Few are scheduled. Big difference!
If you have ever filed for one and actually gone through the process you would know that.
Ampio Unveils Revolutionary Medical Diagnostic [View article]
You are only partially correct but in a misleading way. It is a simple matter to request a Pre IND meeting and many are filed and requested every year but in order to actually have one scheduled, previous trial data better be compelling to the FDA or they will continue to ask for more information until they are satisfied or until you give up. The FDA does not routinely schedule Pre IND meetings unless they are reasonably comfortable with the prior safety and efficacy data and they also take a close look a the scientist.
If a meeting actually materializes, it turns out to be a vetting of the drugs performance and the scientist.
This is why you will see so few announcements of successful Pre IND meetings. Many are filed. Few are scheduled. Big difference!
If you have ever filed for one and actually gone through the process you would know that.
5 Surprising Facts About Hyperinflation [View article]
Ampio Unveils Revolutionary Medical Diagnostic [View article]
see FDA link: http://1.usa.gov/NECoaQ
Pre IND meetings with the FDA are exceptionally valuable but extremely difficult to obtain. Before the FDA will commit to a Pre IND meeting, they require compelling safety and efficacy data from previous trials and compelling information about the scientists developing the drug.
The FDA typically has a staff of anywhere from 12 to 20 highly trained specialists reviewing this information and if they decide to set a meeting most of them will be present. At the point of the actual Pre IND meeting, the FDA has already seriously vetted the drug and the scientist or they would not allocate their time and their experts unless they were compelled by strong data from prior trials and confidence in the scientist developing the drug.
Pre IND meetings are little understood even by institutional investors, but one with successful FDA guidance can offer a high level of confidence to investors because of the intense vetting by the FDA’s large panel of experts.
A Pre IND meeting can result in failure or in profound benefits to the applicant such as a decision as to whether or not the FDA will accept safety data from previous trials that could result in very large time, cost and risk savings. If permitted, this 505(b)2 pathway allows use of the safety data from previous trials.
Another potential benefit to the applicant is that if the FDA is convinced the drug may be helpful to additional indications beyond the one the trial is designed for, they may allow the applicant to include those patients in the trial and if efficacy is demonstrated they may allow the drug to be labeled as being beneficial to those other indications. That could greatly expand the market for the drug in trial.
I hope this helps you dreamdivers.
The Bottom Is In For Gold [View article]
Ampio Unveils Revolutionary Medical Diagnostic [View article]
Ampio Unveils Revolutionary Medical Diagnostic [View article]
Thank you for your comment. Unfortunately his comments have had a negative impact on the shares and it is surprising to me that investors including Adam don't understand what having a successful Pre IND meeting with the FDA means. They are very difficult meetings to schedule and the FDA demands compelling data from prior trials and about the caliber of the scientists before they meet. This meeting is a very strong validation of the drug and the FDA's confidence to move forward.
Anyhow, you are right and the record will be set straight soon.
A Valuation Model For Arena's Belviq [View article]
I wish you well. Diet and exercise are the only answer and the FDA and all health institutions know it and tell us that but very few people have the awareness that it takes to make the change to really see.
Just take a look at a healthy person who eats healthy food and who exercises. ONly 4 years ago I was obese, had extremely high blood pressure, extremely high blood sugar and was borderline diabetic, parkinsons dystonia, spiked PSA, disabling arthritis in my hands and not feeling very good. I was very close to death.
I changed my doet and at 70 years old I am lean and the strongest I have been in 30 years, no diseases remain, no medications, none, blood pressure of 110 over 65, resting pulse rate of 60, enough energy for 5 teenagers and I my mind is the sharpest it has ever been.
Life is amazing when you feel good the way we are all meant to.
I would be happy to share my know;edge with you.
Today, I am working with the world's leading nutritionist, Dr. Joel Fuhrmanto bering the most powerful all natural foods to your table that taste incredible.
Great stuff and the best of luck to you.
A Valuation Model For Arena's Belviq [View article]
Diet pills are a good start but they are only that. ONLY diet and exercise work.
A Valuation Model For Arena's Belviq [View article]