No argument there, AF is def a dick. But his resp
Post# of 30065
(Total Views: 598)
Posted On: 01/05/2018 11:48:15 PM
No argument there, AF is def a dick. But his response is rooted in truth.
Let’s look at Orphan status vs FDA Fast tracking:
"Orphan Drug" status and "Fast Track" designations generally mean the drug will be moved to the open market faster.
"Fast tracking" is allowed by the FDA when drugs in their experimental trial phase vastly exceed expectations and/or the drug works so much better than placebo in the drug's experimental trials that those getting placebo are clearly worse off (that it would be inhumane to give them placebo when the alternative works so much better). Fast tracking is usually given after excellent results during Phase II or Phase III trials.
The FDA's drug approval process usually takes many years, and "fast tracking" shortens that time considerably.
The advantages to fast tracking are:
1. to the drug manufacturer because they have longer patent time to sell the drug without competition
2. to the patients in the general public (who are not in the experimental phase of the drug already) who may potentially need these drugs because they can get their hands on them sooner
3. to investors in such drug companies as news like this often causes their stock prices to jump
"Orphan drug" status is not as desirable. Orphan drugs are technically drugs that are required but its use will be relatively infrequent (so it's not gonna be a big money-maker). To make this easier to understand, let us say that company XYZ comes up with a drug that treats condition/disease ABC. However, condition ABC only affects, say 50,000 people. It is a legitimate disease, but it is unlikely company XYZ will profit from making the drug to treat this condition ABC. Most companies are truly in business only to make money, so company XYZ really has no reason to produce this drug because it won't make them any money. But what about the 50,000 people who have this disease? Will they be forced to suffer, even though a cure exists? So what the FDA does to remedy this problem is grant company XYZ's drug "orphan drug" status so that it has exclusive patent rights to this drug, AND probably pays the company some kind of grant money or something so that it will offset the losses that XYZ would incur by producing this non-moneymaking drug.
There is little incentive for many pharmaceutical companies to develop cures for rare diseases - those that affect fewer than 200,000 people in the US - because the small market and high cost associated with finding these types of cures discourages these companies from entering this market.
If Elto was the only thing out there to treat PLID (Adamas beat them to market) or Alzheimer’s Aggression (several companies are going through Phase III trials) The there would be a chance someone would jump. But, any pharma company knows to recoup the money for trials done on a generic drug for a rare disease is not possible unless they charge $35k+ a year. They would get skewered for this (See Epi Pen). Thus no company has been interested.
So yes, the patents, the orphan drug designation are all nice “feel good” PRs, but they ultimately mean nothing because no company as of yet sees ELTO as being worth a dime.
And you are right, big pharma has scores of people investigating this opportunities every day and ELTO is not currently on any of their radar as a product of interest. ELTO will not be the catalyst to get us to uplist. It is ESS and MANF near term, maybe MSPrecise, case closed. ELTO is not the gem, it’s a “hey, by the way, to sweeten the deal we are trying to get done for MANF or ESS, we’ll throw in Elto free of charge.
Let’s look at Orphan status vs FDA Fast tracking:
"Orphan Drug" status and "Fast Track" designations generally mean the drug will be moved to the open market faster.
"Fast tracking" is allowed by the FDA when drugs in their experimental trial phase vastly exceed expectations and/or the drug works so much better than placebo in the drug's experimental trials that those getting placebo are clearly worse off (that it would be inhumane to give them placebo when the alternative works so much better). Fast tracking is usually given after excellent results during Phase II or Phase III trials.
The FDA's drug approval process usually takes many years, and "fast tracking" shortens that time considerably.
The advantages to fast tracking are:
1. to the drug manufacturer because they have longer patent time to sell the drug without competition
2. to the patients in the general public (who are not in the experimental phase of the drug already) who may potentially need these drugs because they can get their hands on them sooner
3. to investors in such drug companies as news like this often causes their stock prices to jump
"Orphan drug" status is not as desirable. Orphan drugs are technically drugs that are required but its use will be relatively infrequent (so it's not gonna be a big money-maker). To make this easier to understand, let us say that company XYZ comes up with a drug that treats condition/disease ABC. However, condition ABC only affects, say 50,000 people. It is a legitimate disease, but it is unlikely company XYZ will profit from making the drug to treat this condition ABC. Most companies are truly in business only to make money, so company XYZ really has no reason to produce this drug because it won't make them any money. But what about the 50,000 people who have this disease? Will they be forced to suffer, even though a cure exists? So what the FDA does to remedy this problem is grant company XYZ's drug "orphan drug" status so that it has exclusive patent rights to this drug, AND probably pays the company some kind of grant money or something so that it will offset the losses that XYZ would incur by producing this non-moneymaking drug.
There is little incentive for many pharmaceutical companies to develop cures for rare diseases - those that affect fewer than 200,000 people in the US - because the small market and high cost associated with finding these types of cures discourages these companies from entering this market.
If Elto was the only thing out there to treat PLID (Adamas beat them to market) or Alzheimer’s Aggression (several companies are going through Phase III trials) The there would be a chance someone would jump. But, any pharma company knows to recoup the money for trials done on a generic drug for a rare disease is not possible unless they charge $35k+ a year. They would get skewered for this (See Epi Pen). Thus no company has been interested.
So yes, the patents, the orphan drug designation are all nice “feel good” PRs, but they ultimately mean nothing because no company as of yet sees ELTO as being worth a dime.
And you are right, big pharma has scores of people investigating this opportunities every day and ELTO is not currently on any of their radar as a product of interest. ELTO will not be the catalyst to get us to uplist. It is ESS and MANF near term, maybe MSPrecise, case closed. ELTO is not the gem, it’s a “hey, by the way, to sweeten the deal we are trying to get done for MANF or ESS, we’ll throw in Elto free of charge.
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