Posted On: 09/20/2014 11:03:53 AM
Post# of 30034
Only 1 in 10 INDs ever make it to market!! Think of all the people who invested in the compounds of those 9 out of 10 INDs that ultimately failed!! Were they all stupid? Were the companies developing those drugs inept? No. By the time a drug makes it to the IND level....it is showing great promise, enough for companies and investors to take it to the next step. But the scrutiny for a drug to succeed is so great, and the opportunities for failure all along the way are so numerous....that it behooves investors in Bio-tech companies developing these drugs to use extreme caution because it is a very risky process. Read the following short explanation of the drug development process.
http://www.wikinvest.com/wiki/FDA_approval_of_drugs
I think MANF and Eltoprazine have better than 1 in 10 odds. Eltoprazine is well past the IND stage, it is entering a Phase 2b trial. It has already had several hundred people tested. (700?) So instead of 1 in 10, it's odds might be 1 in 2? I think David Lowe's reputation and the fact he had an inside track on this drug bodes well for us. Also, because there are no drugs currently treating LID, the FDA might be a bit more lenient in giving it approval if it's testing results are good.
MANF has not yet submit an IND, but is close. But I would also give it better odds than the 1 out of 10. John Commissiong is no run of the mill scientist. He has worked at the NIH as a Department Head and has worked on drugs that have received FDA approval. He has made sure that MANF's pre-clinical research has been far more thorough than most pre-clinical drugs so that the likelihood of surprises once it gets into clinical trials is lessened. Plus, we are focusing MANF on orphan diseases first, which the FDA is more eager to approve. And, the fact it isn't likely to have toxicity problems since it comes from human protein, all combine to make MANF an excellent bet to one day get FDA approval!
But it is still a bet!
I too want this message board to succeed. But I think it is important for us longs to always remember we are investing in one of the most risky investments there is: drug development! We're not investing in a Bank CD with FDIC guarantee of principal! Having a cautious almost skeptical view of the drug companies we invest in is really the only way to add a degree of safety to the risky endeavor we've embarked on. I never, never, never take for granted that a pre-market diagnostic (in LymPro's case) or pre-clinical drug (in MANF's case) is guaranteed to succeed. I'm not only that way about AMBS, but I'm that way over every drug company I've invested in. (Not that I'm an expert, by any stretch) I've sold life insurance, mutual funds, and annuities for nearly 30 years, investments which don't have nearly the risk AMBS has, nor the potential return. Thus the name: Riskreturn.
I get it, trust me. But I will continue to be positive and negative on various aspects of AMBS as I feel appropriate, but I'll try to be polite as possible while doing it.
http://www.wikinvest.com/wiki/FDA_approval_of_drugs
I think MANF and Eltoprazine have better than 1 in 10 odds. Eltoprazine is well past the IND stage, it is entering a Phase 2b trial. It has already had several hundred people tested. (700?) So instead of 1 in 10, it's odds might be 1 in 2? I think David Lowe's reputation and the fact he had an inside track on this drug bodes well for us. Also, because there are no drugs currently treating LID, the FDA might be a bit more lenient in giving it approval if it's testing results are good.
MANF has not yet submit an IND, but is close. But I would also give it better odds than the 1 out of 10. John Commissiong is no run of the mill scientist. He has worked at the NIH as a Department Head and has worked on drugs that have received FDA approval. He has made sure that MANF's pre-clinical research has been far more thorough than most pre-clinical drugs so that the likelihood of surprises once it gets into clinical trials is lessened. Plus, we are focusing MANF on orphan diseases first, which the FDA is more eager to approve. And, the fact it isn't likely to have toxicity problems since it comes from human protein, all combine to make MANF an excellent bet to one day get FDA approval!
But it is still a bet!
I too want this message board to succeed. But I think it is important for us longs to always remember we are investing in one of the most risky investments there is: drug development! We're not investing in a Bank CD with FDIC guarantee of principal! Having a cautious almost skeptical view of the drug companies we invest in is really the only way to add a degree of safety to the risky endeavor we've embarked on. I never, never, never take for granted that a pre-market diagnostic (in LymPro's case) or pre-clinical drug (in MANF's case) is guaranteed to succeed. I'm not only that way about AMBS, but I'm that way over every drug company I've invested in. (Not that I'm an expert, by any stretch) I've sold life insurance, mutual funds, and annuities for nearly 30 years, investments which don't have nearly the risk AMBS has, nor the potential return. Thus the name: Riskreturn.
I get it, trust me. But I will continue to be positive and negative on various aspects of AMBS as I feel appropriate, but I'll try to be polite as possible while doing it.
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