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bag, You surprise me, that's beneath even you.
Oh well, if what you say is true, then perhaps you can eat it, while your accomplice barks at the moon.
DorseyE, Congratulations.
You should put out a PR!
Easyman,
Try to find something that a government 'won't' fork over cash for. The list of pork barrel nonsense and $800 toilet seats is a neverending litany of the foibles of government spending.
There are thousands of companies that derive their entire parasitic existence from the neverending spigot of government largesse. They never have to prove results or demonstrate that they are earning their keep, they just keep sending in their grant requests.
That this grant gives a hint of a promise that future sales 'may' be contingent on the results of the validation, is at least a positive factor in the long long list of negatives that have occured. To suggest that after 5 years, a $40K grant is evidence of significant momentum is a bit of a stretch.
This thread started with the discussion of whether the latest PR was or was not fluff. It has since degenerated into a discussion over the inherent value built into such a 'validation' by the Australian Government. However if we discuss the grant in it's simplest terms; a very small amount of money, to provide a service that could (or should) have been done by the company on it's own, in order to qualify a new feature (Retinome) to an already existing platform (DNAWitness), that then 'might' be purchased by the police on a case by case basis, then it takes on a more fluff like aspect.
Remember that Frudakis himself has suggested that the Forensic side of the business, while eventually having the potential to become self sustaining will 'never' be a big money maker. So we have a SMALL amount of grant money that MIGHT lead to a few more sales of a SECONDARY product, all of this appearing in the framework of an investment community on the edge of its seat regarding the completion of a major deal that so far has not been mentioned by the company for months.
It is not surprising in this context, that those who are so desperately wishing for news of any kind have grasped this latest missive to their bosom and cling to it fervently as validation of their investment prowess, but at the end of the day, it is fluff, pure and simple.
regards,
frog
Chris,
Thanks for agreeing.
In return I will agree to one of your statements, with one caveat.
"If DNAP had convinced the world at large, I would be rich right now."
If they had convinced the world as well as they have convinced you, you would be rich.
As far as;
"And as it does, DNAP will become stronger and stronger. I wish you could see that."
I wish I could see it too. lol
regards,
frog
Ahh, witty repartee.....
How I miss it!
mikenickels,
>> "Once again, the real point is that the Austrailan government is obviously interested in this product, and might make it a standard part of their forensic tool kit."
----
How unfortunate for them that the information necessary to give them some confidence in it's performance is not readily available.
Perhaps the 'real point' is that DNAP has not yet convinced the market that they have done their homework.
regards,
frog
mikenickels, If it's not just fluff, then it is pretty discouraging news.
$40,000 to carry out a validation of Retinome. Think of the questions that raises.
Isn't Retinome already validated?
Has it been released without sufficient validation?
If it has already been validated, why does the Australian Government not accept the data, why does it need to be redone?
$40,000 dollars, gimme a break, can't DNAP perform it's own validation and present the results in such a way as to satisfy those involved without approaching them with hat in hand for such a paltry handout?
Doesn't appear to be the behavior of a major player, does it?
Let's hope it was just fluff...what do you think?
regards,
frog
Gunnabe,
According to our friend bag8ger there have been a couple hundred million shares issued since the deal was announced.
If those shares had been dumped into the market via the the LaJolla transaction, the pps should have dropped proportional to the number of shares involved, it has not.
Therefore it would seem evident that the shares have entered the float via some other avenue. As the Dutchess transaction is the only other game in town, that we are aware of, in which so many shares could be involved, it seems reasonable to assume that the deal is active.
The possibility that Dutchess is also buying shares on the open market exists, although I was not refering to that. On the other hand, as I have mentioned before, Dutchess seems to be in the process of acquiring a controlling interest in DNAP, so buying shares on the open market would not be out of line.
regards,
frog
It's a pretty safe bet that the deal has gone down. The circumstantial evidence all points to a completion of the arrangement.
Biofrontera has ammended their list of Directors to include the DNAP additions.
There has been a huge increase in the issued shares since the announcement of the deal and yet the pps has not dropped proportionally. There is evidently an entity buying up the extra shares just as one would expect if Dutchess was acumulating their slice.
If the deal had failed, the market would have already started to react and the pps would have dropped on increasing volume in the last few days.
I don't expect any bloodbath next week.
regards,
frog
I expect the drama is already out of it.
Given that close of business has occured on the last day before the deadline, either the deal has already happened (as the peripheral evidence would indicate) or else it has been abandoned.
In either case, the market is aware of what has transpired and has already factored the change into the value of the company.
I suspect that aside from a brief flurry of activity by a few investors waiting for an actual announcement before they react, there will be little change in the next week.
regards,
frog
go Pats!
NIH to make research publicly accessible
By Mary Mosquera
GCN Staff
The National Institutes of Health is asking scientists to voluntarily make their biomedical research results available through the agency’s searchable database within 12 months of their publication.
NIH wants to accelerate the public's access to published articles resulting from its funded research.
NIH, an agency of the Health and Human Services Department, originally proposed that scientists who receive NIH funding provide it with electronic copies of all final research manuscripts upon acceptance for publication. The agency would then make the research publicly accessible in six months. During the comment period, some journal publishers were among those critical of the quick turnaround.
The National Library of Medicine will manage the Web archive at PubMed Central, its digital repository of peer-reviewed biomedical, behavioral and clinical research journals. PubMed is a publicly accessible and searchable electronic archive.
“While this new policy is voluntary, we are strongly encouraging all NIH-supported researchers to release their published manuscripts as soon as possible for the benefit of the public,” said NIH director Elias Zerhouni yesterday in announcing the final policy. NIH tried to balance the importance of public access with the needs of scientific authors and their publishers, he said.
Beginning May 2, the policyrequests that NIH-funded scientists submit an electronic version of the author's final manuscript, upon acceptance for publication, resulting from research supported in whole or in part by NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the peer review process.
Scientists applying for new and competing renewal support from NIH will be able to provide links in their applications to their PubMed archived information, which will help streamline the application and review process.
Grateful, Not much perhaps but something.
If you have been following the topic here for the last couple of days you will have noticed the hyperventilation that grew out of the latest PR. It was suggested that the selection of DNAP for an NIH grant indicated a validation of the science by the government and an effort by the government to force 'institutions' to take up the technology.
I was just offering my experience with the procedure as a counterpoint to that hyperbole.
regards,
frog
I am currently involved in a NIH grant. It was applied for by a research company in the northeast associated with a major university in Pennsylvania. My company participated as a sponsor. Essentially writing a letter to NIH suggesting that this particular technology might have some application in our industry and providing some oversight to the project.
The grant was for $100K and extended for two school years. The phases involved gathering data and developing an algorithm for it's analysis for the first year and the deveolpment of a computer simmulation of the final device. The next year is dedicated to creating a Proof of Concept (POC)device. The device will be finished some time in March.
All NIH expects is a report based on the test results derived from the POC device. At that time the grant will be concluded.
As a point of reference, there are no requirements or expectations from NIH.
It is the hope of the research company that the company I work for, as the sponsoring organization, will take up the continuation of the project and upon it's completion, license the technology within our industry. Given the test results so far and the state of the industry in regards to this particular technology this is not very likely.
The reality is, that this research company exists solely by applying for, and receiving these types of grants from the NIH, DARPA and whatever other government agency is providing them. They have been in existence for years and have not yet hit a home run. They, and the myriad of companies like them who derive their sustenance from these grants are supported by the benevolence and generosity of the government who provide these minor dollar amounts with very little oversight or involvement in the hopes that the technologies will benefit from the occasional success story.
regards,
frog
And good looking!
"institutional" is a word taken from a PR put out by one of the companies involved in the grant request.
It reflects one of the possible uses of any benefit that might originate from the issuance of that grant.
It does not imply any indication by the NIH or any other government agency that they either agree or endorse such a possibility.
It certainly does not predict any effort by the NIH or any other government agency to promote or recommend the use of the aforementioned possibility.
If one takes the time to review the thousands of grants issued by the NIH on a yearly basis, and then correlates any successful outcomes of those grants against any public effort by the NIH to promote any of them, the complete absence of such may assist in the decision on whether or not one wants to "run with it".
regards,
frog
OT: Miss Scarlet
I am glad you have returned to the board your absence was noted. I have not received any recent messages from you.
best regards,
frog
worktoplay,
I have a question for you regarding this line of speculation. It will be difficult for me to word in such a way as to not set of the regulars as negative spin, but I will attempt it anyway with the disclaimer that such is not my intention.
It is apparent that Gabriel and Tambori once held a fairly significant fraction of Biofrontera ownership. That share has recently dropped to a low level via the dilutive effects of new investments. Prior to that dilution Gabriel became associated with DNAP and the current strategy of drug pipeline acquisition was first broached.
The sequence of events that you have documented so carefully is much too focused to be coincidence and the plan seems to be one that has been in the works for years. Clearly Gabriel set out to bring DNAP and Biofrontera together from the start.
We, as a group, have been viewing the Biofrontera 'acquisition' from our own DNAP-centric viewpoint, but the driving force behind the association would seem to have originated with Gabriel before he connected up with DNAP. Would you agree?
Now here's the hard part of the question. Without raising the spectre of conflict of interest, does it not appear obvious to you that this deal reflects a larger picture in which some entity is financing the gathering together of a number of smaller companies into a larger conglomerate and is using DNAP as something of a front in that effort?
I can't escape the felling that DNAP is being carried along like a small boat adrift on a river. Seemingly moving in the right direction and moving quite fast, yet not necessarily in full control of the tiller and lacking any means to stop.
regards,
frog
retro, It is quite possible.
Another explanation for the discrepency between the apparently minor 1.3% investment and the Major Investor label, might be the recently reported investments and the dilutive effects of such transactions.
One can only speculate as to the number of shares that must have been offered for the $20 Million VC investment that preceded DNAP's $25 Million deal. If a number of shares equivalent to 51% of the total had to be issued for DNAP, it is fairly obvious that a significant number needed to be issued to cover the previous investment. It does not require much imagination to come up with a scenario in which DNAP and the $20 Million investor now control shares in the 80% to 95% range, and the previous 'Major Investors' have had their majority ownership diluted to the present low values.
So, it is quite possible that the Major Investors listed previously on the web site, have not given up any shares but have actually lost their majority ownership due to the dilutive effect of the stock issuance.
regards,
frog
worktoplay, Thanks for the clarification. The listing as a Major Investor is certainly misleading if, in fact, Gabriel's and Tambori's ownership totals less than 1.3%.
I note that our gender confused friend on the Naphead board is suggesting that some fraction of the couples Biofrontera ownership is held under the Pharm Eco umbrella and therefore doesn't show up as personal holdings. I have no idea if this is true or not, but it would explain the incongruity of the 'Major Investor' label.
If it is true it would also reopen the conflict of interest discussion.
http://ragingbull.lycos.com/mboard/boards.cgi?board=CLB01189&read=3565
regards,
frog
bag8ger, Here's something else I find interesting.
>> "I always have found it interesting to read the things you find interesting.
Even they have no import to me, or I suspect, to most of this board, and although you point out they are mostly for argument's sake, I have noticed they are always observations negative to DNAP and, to not the least, its shareholders."
---
I find it interesting that you rarely miss an opportunity to respond to one of my posts, yet you seldom ever respond to the point being made. You seem bent on turning every conversation into a morality play with you in the role of innocent victim.
Put down your violin bag, the dirge is starting to grate.
Now back to the subject at hand. Do you have an opinion on what the 'less than 1% each' statement is refering to?
regards,
frog
You know, I've always been curious about that 'less than 1% each' value offered by Gabriel and Tambori to dampen out the concern about a conflict of interest.
As we all know, from the truffle hunting performed on these boards under the guise of DD, Tambori and Gabriel have been listed on the Biofrontera web page as two of about six investors for months before the deal was announced. As soon as the announcement occured there was a significant reaction from some investors questioning the ethical nature of such a deal where the CEO of one company buys up another company in which he is a major investor. The questions were put to bed fairly early with the 'less than 1% each' statement.
My question is, One percent of what?
After the deal is reported the 'announced' value of the company (based on the $25 Million dollar investment by DNAP) is said to be over $50 million dollars. If we apply the 'less than 1% each' value to this $50 Million dollar apparent value of the company we see that any investment up to $500,000.00 each would fall below the threshold. So they could easily own collectively a million dollars worth of Biofrontera and still meet the terms of the 'less than 1% each'.
However, before the deal is announced the value of the company is actually significantly lower. Lets assume for arguments sake $5 Million dollars. (Based on the reported price of $2.7 Million being paid by DNAP for voting control of 51% of the stock). Now that $1 Million dollar investment of Gabriel and Tambori looks like 20% of Biofrontera, and would appear to offer evidence of a potential conflict of interest.
So which is it? Less than one percent of the $50 Million 'after' the announced deal, or less than one percent of the actual stock of Biofrontera before the announced deal?
And before anyone has a fit about the values offered here, they are clearly indicated to be 'for argument sake'. I am just pointing out the possible interpretations of the statements. I have always found it interesting that the share of Biofrontera owned by Gabriel and Tambori was disclosed in such a vague manner. 'Less than one percent', as a stand alone statement, is meaningless. A more meaningful value would be percentage of shares or dollar value of the investment. Neither would be subject to interpretation, and neither would give the appearance of sleight of hand.
regards,
frog
Probably. I imagine everyone in the industry was solicited for input.
It was a rhetorical question. lol
It costs an average of $900 Million to develop a new drug. It is obviously 'more profitable' to reincarnate previously developed drugs than to start over with new drugs.
You are correct, the guidance hasn't prevented anyone from developing classifiers, and all those classifiers are just waiting for the 'forms' and the rules for the approval process.
The 'reason' the FDA is developing the guidelines is that the industry has a number of products developed that they want to move forward on, but they can't go anywhere until the templates have been designed and the appropriate designators have been standardized and the approval process has been released.
Go ahead and doubt. That's your perogative.
As to 'inclination'....how many powerful and effective superdrugs are sitting on the shelves of big Pharma, having failed the approval process due to unacceptable side effects at the last stage?
There are billions of dollars in revenue already locked and loaded, just waiting for the FDA to define the acceptance criteria.
Big Pharma may be the 'enemy' but they are both powerful and smart. The obvious benefit of drug classifiers has been obvious to the world since before the Genome project started. Why do you think the FDA is developing the guidelines.....for DNAP?
It is far more efficient for big Pharma to work their way back through their catalog of already developed drugs than it is to develop new ones from scratch.
It is OK to bet against such obvious ramifications of the developing industry, that is also your perogative....but don't bet much!
regards,
frog
As soon as the industry and the FDA agree on how classifiers will be identified and approved, I expect the market to be inundated by them.
I expect the approval process to be analytical, based on previously obtained genomic data. (obtained during the formal phases of the drug approval process).
I expect all of the players in the pharmaceutical arena are quietly biding their time awaiting the go ahead from the FDA. Their data has been available to them forever, they have had more than enough time to distill the classifiers from the data. They have already kept a large portion of their data untouched and 'clean' in order to facilitate the verification process as soon as the FDA establishes the guidelines.
So, yes, I expect drug classifiers to be the next big push in the pharmaceutical industry. They will heavily leverage the Vioxx and Celebrex issue to promote them, and personalized medicine will have arrived.
I will not necessarily sign up to the 2005 date that you have proposed, as the development of the playing field seems to be progressing at a snails pace, but the players are ready whenever they blow the whistle.
regards,
frog
It was simple enough.....as I thought the response was.
If you want people to do your DD for you, then ask a specific question. Tell us the parts that confuse you and we will try to help.
If you need the whole thing translated into simple terms, I am sure there are many here who will be glad to oblige. I am afraid that there is too much water under the bridge between us for you to ask such a favor from me. lol
regards,
frog
DougS, Sorry for the delay, I am home this week and have been working on getting the boat ready.
I must say that you are getting better at that patronizing condescension that ming used to try. He was better at it because he had the credibility to carry it off, but don't give up.
As to the guidance, I think it is you who needs to 'look it up'.
If you think that FDA guidance; "..designed to encourage drug makers to use pharmacogenomics technologies in their drug-discovery efforts" doesn't relate directly to classifiers and the technology that enables them, then forgive me for giving you credit for a greater level of perspicacity than you evidently possess.
regards,
frog
Ifida, It looks like the document is imminent.
The first draft was over a year ago, a couple of deadlines have passed for it's release and now it looks ready to go.
"The widely anticipated document....."
Hmmm....widely?
Who do you suppose is waiting for it (outside of DNAP investors that is)?
I wonder who has been driving this document with the FDA, who do you suppose has the clout to demand guidance from the FDA?
Who has reams and reams of data from their thousands of drug trials, even the 'failed' trials that could be resurrected if classifiers could be considered?
Why do you suppose the document has had to be rewritten so many times over the last year?
Perhaps it needed to be adjusted in order to accomodate all of the classifiers waiting in the wings. It is doubtful that a "guidance" document from the FDA would be "widely anticipated" if there weren't a number of products waiting on it's release.
regards,
frog
ice, Good point.
>>The real benfit to pharmacogenomics will be the reduction in side effects of medications and taylor made compounds to ones genetic profile.
The first manifestation of this benefit may well be the classifiers that will make today's crude drugs a little safer for those who may be susceptible to the side effects.
It is important to note that the technology that permits the development of the classifiers will also assist in the development of more advanced drugs that will not have dangerous side effects.
We are currently on the seemingly glacial cusp of a paradigm change in the development of new drugs. New compounds have been essentially developed via a hit and miss guessing game that tests drugs against an array of diseases and then weights the potential benefit of the compound against it's side effects to determine whether it is a viable treatment. (note; This is a generalization of the process that does not intend to demean the hard work and academic proficiency necessary to carry out the complexities of the task.) Such drugs lend themselves to the development of statistically based and equally crude classifiers. However, as the secrets of the genome unfold, new compounds will be derived that are specific to the diseases that they target. They will be biological 'smart bombs' that will kill only their target without harming any other systems. They will not have side effects and will not need classifiers.
The window of opportunity for drug classifiers will not be very wide. Especially as the first generation of targeted treatments are even now entering the approval process.
regards,
frog
OT Phil,
Don't forget my disdain and patronage!
Merry Christmas
Chris, There is certainly nothing that I would expect you to understand.
Merry Christmas
DRCAL
If you're going to make up numbers..."only a few people die, say 50,000-125,000 per year, due to drug interactions ..."
Then perhaps you can tell us how many people lived?
Tell us how many of them are taking not just pain killers, but life saving therapies?
Tell us how many would have died if there were no drug?
After you have those numbers in hand and have had time to analyze them, tell us which number is bigger?
Then tell us what YOU would have done when the decision had to be made whether to allow the drug to be used, even 'knowing' the potential side effects?
How many will YOU sacrifice to save millions? A thousand? A hundred? One? What 'ratio' is acceptable and what ratio is 'gross'?
regards,
frog
Excellent examples of risk assessment and management, bag. Thanks for the support. lol
In case you missed the point of my post entirely, I will try to clarify it.
The present hysteria in regards to adverse drug reactions is the issue that cannot be resolved, not the diseases themselves.
There will always be hard choices to make, people willing to make them, and hysterical nitwits who will condemn those choices. That is an unresolvable facet of human nature.
Emotion and reason are polar opposites.
As I have shown by example (aircraft and auto) and you have confirmed (flu, polio and smallpox countermeasures), risk management will always be with us. The ignorant among us will continue to make emotional fodder out of the fallout.
While the present hysteria may offer some leverage in advancing a reasonable advance toward drug classifiers, it is nevertheless based on ignorance and hypocricy.
regards,
frog
Bag8ger, The dilemma will always exist, only the weighting factors can change. It is simplistic to assume that even 'IF' DNAP could create effective classifiers, then the problem would go away. If anything it would add to the problem.
Effective drugs are being pilloried because of certain low levels of adverse side effects. DNAP could obviously reduce the occurence of the effect by developing effective classifiers. They will NOT eliminate them, their own data shows a certain level of effectiveness but it is NOT 100%. Some people will still die.
Carry the concept to the next level. What happens when a drug is developed that absolutely cures a major disease (lung cancer, diabetes or heart disease) but it's side effects kill 50% of it's patients. If DNAP can reduce that effect to 1% will that be good enough? 0.5% ? 0.001? Where will you put the limit?
Like I said the hard decisions will still need to be made. DNAP may be able to help with the trend toward safety but only an idiot would expect them to 'resolve' the problem.
Ann,
Given your obvious leaning and board affiliations, I am surprised at your suggestion that no one can predict 'what's at the end of this tunnel!'. Most of your brethren are continually predicting great things. "To Da Moon" being one of the more intellectual of the predictions.
I'll be happy to predict your fortune though.
According to my crystal ball, I see disappointment in your future.
Merry Christmas.
frog
Unexpected Adverse Drug Reactions......Who's to Blame?
The latest panic and the most fashionable story on the nightly news this week. Unfortunately it will eventually fade away as it is an unresolvable dilemma. Whenever emotional panic confronts the reality of reasonable risk management, there are no easy answers.
The hard realities are that there are very few easy decisions in the drug business. How do you weigh the suffering of millions against the potential death of a few?
The emotional among us are, even now, in pious tones, saying "the choice is obvious....lives are sacred".
This simplistic mindset is obviously untenable at the outset, as such a viewpoint would immediately shut down such major sectors as commercial air travel and the automobile industry, while both have major beneficial aspects they also carry a major liability in adverse side effects.lol
The final outcome of the latest FDA turn on the media hotseat, will be a few studies and a great deal of political posturing by those willing to use the forum for personal attention. The end result may be some adjustment in the weighting of the various factors (1 death is equal to the suffering of ??? million victims) but that is all. The hard decisions will still have to be made and a bunch of people will step up to the plate and make those hard decisions, even though they will never get credit for them but will inevitably get blamed, the next time the media spotlight revolves around to them.
regards,
frog
Ann441j, Please tell me you are not serious....Please!
Get real. The financing package is primarily designed to fund the bonus!
WOW! You should change your alias to 'windsock'.
Do you just chose investments with a dartboard?
You show up here as a self proclaimed expert and DD master, you threaten litigation against any poster that disagrees with you or suggests doubt about the company, and then in the blink of an eye you abandon it. The trigger for your abrupt turnaround seeming to be an item in the very latest filing by the company, a filing that one would expect would be the very first place a DD novice would start his investigation.
Talk about clueless.
I am afraid, my friend, that you have just divested yourself of any vestiges of credibility that you may have left.
regards,
frog
theanswermyfriendisblowinginthewind...
Bag, lol
Did you just call me a sparkling gem?