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To: twentyfirstcenturyfox who wrote (9033)3/15/2002 6:05:09 AM
From: axial  Read Replies (1) | Respond to of 14101
 
Hi, fox -

You may not be aware that there is a persistent crowd of bashers who inhabit DMX investor threads. These posters, who are known, have persistently and repeatedly posted unsubstantiated allegations and insinuations of management incompetence (and lately, management dishonesty).

These posters have neither evidence nor logic to support their comments: they rely on a troubled history, and from that, they extrapolate to management-bashing.

While there is room for improvement in many aspects of DMX's functions (no blank check for management here!), I have never felt that the explanation is that simple. It's just too easy, and there is no evidence to support the conclusion that DMX's course has been guided by stupidity, or dishonesty.

The bashers have shown a regrettable lack of intelligence and diligence in their accusations. Basically, their dim-witted and constant assertion has been that if DMX is having problems, it must be management's fault.

Opinions are being manipulated by people who don't have the horsepower to think these things through, don't have the work ethic to do the research, and don't have the intellectual honesty to consider anything but their own blind, malicious aspersions.

Over the last couple of months I have tried to discover some real reasons for the difficulties that DMX has encountered.

My first avenue was the possibility of anti-competitive practices by other pharmas, working through the medium of political contributions. I still regard that as a likely effort on the part of competitiors; the question of how much it has succeeded is not "knowable", IMO.

However, a recent comment by Padco brought forth a more important factor.

That is - the difficulties and delay being encountered by DMX result from the unconventional nature of these drugs.

In the case of Pennsaid, the issue was DMSO.

In the case of WF10, the issues were -

(a) Divergence from conventional thinking regarding approaches to immunotherapy
(b) Difference from conventional thinking regarding substances for therapy (IMO, many wrongly view WF10 as a fortuitous and chemical approach, as opposed to an approach with its roots in biology and medicine): misperception.

The evidence available to those who have researched this subject is that both of these therapeutics are efficacious, and safe.

These questions were brought into focus by the recent NON by HC. I consider HC to be the Cowardly Cousin to FDA.
_______________________________________________________

WRT your questions about approval...

"...is there not likely to be a built in bias, at FDA, against approving any medication with DMSO in it?"

I think it is very likely that DMX has overcome that bias.

Based on the information we have now there is little doubt that Pennsaid will be approved by FDA, and subsequently, (we hope) by HC.

Approval is 99% accomplished IMO.

I can see where an investor might have been concerned 2 years ago. But the fact that the factory has been inspected, and has passed (plus the fact that such inspections are generally only given to favorably-viewed drugs) - means that it is almost a certainty that Pennsaid has overcome the FDA bias against DMSO. Please refer to other posts, especially those that show the flow-chart of FDA approval.
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"Are you aware of DMSO being used as a transdermal carrier for any drug other than in Pennsaids?"

- No. Not that I'm aware of. Obviously, if Pennsaid is approved, this gives it a tremendous head-start on competitors. I repeat the evidence is that Pennsaid is 99% through the process of approval.
____________________________________________________

"Has any other drug using DMSO been approved by the FDA?"

- Not that I'm aware of. I think Pennsaid will be the "ground-breaker". And, I think REK and DMX will merit the thanks of millions of people for their refusal to bow to conventional thinking.

Regards,

Jim

_____________________________________________________

Some links...

fda.gov

acmed.org

fda.gov

The following two are of interest ;- )

http://www.pharmcast.com/PatentToSubWeb/Classification/Classification1000.htm

pharmcast.com;



To: twentyfirstcenturyfox who wrote (9033)3/16/2002 1:54:01 AM
From: axial  Read Replies (1) | Respond to of 14101
 
Fox, more evidence that the attitude towards DMSO is changing. While Pharma 21's efforts don't constitute approval it shows a change in FDA mindset towards DMSO...

pharma21.net

(Excerpt)...

"Summary of PHA-52 pre-clinical studies
Dimethyl sulfoxide (PHA-52) has been shown to be a powerful free radical scavenger 30-34 with antiinflammatory and cell membrane stabilizing activity. 35-37

Dimethyl sulfoxide has also been shown to lower brain edema in animal models including rhesus monkeys, and in humans.26,27, 38-40 Dimethyl sulfoxide has the ability to increase cerebral blood flow (CBF) following a variety of cerebral insults, possibly as a result of reducing tissue edema and lowering cerebrovascular resistance.21-23, 33,39 DMSO has been reported to improve neurologic and functional outcome after induced brain ischemia in animals, including non-human primates.41-46

In addition, dimethyl sulfoxide has been shown to be a sodium channel blocker. 28,29 Drugs that block voltage-dependent Na+ channels have been shown to exhibit strong, neuroprotective activity in animal models of brain ischemia/hypoxia and a number of clinical trials are now in progress to test these class of drugs when cerebral ischemia is present. 47-50 The Na+ channel blocking activity by dimethyl sulfoxide,28,29 could in part explain its beneficial effect when administered to patients presenting with high ICP secondary to severe, closed head injuries 26,27 or in the presence of cerebral bleeding resulting in clinically elevated ICP.22"


Later...(emphasis added)

Present status of PHA-52
PHA-52 is presently ready for human trials in the treatment of severe head injury. Pharma 21 has been granted an IND (investigational new drug, NR 39,262) by the FDA and Orphan Drug Product status (NR 94-813) giving the Company exclusive marketing rights for seven years after PHA-52 reaches the market. Company anticipates "fast-track" review by the FDA since PHA-52 is aimed at a "life threatening" injury. Fast track review also means that PHA-52 could be approved for marketing after phase II testing instead of the customary phase III requirement by the FDA. This could result in substantial Company savings in time and money and could result in an earlier generation of revenues to the Company.

________________________________________________

[Edit: The fast-track info was bolded for its potential relevance to WF10]
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The combination of extensive prior basic research, prior human studies, prior FDA approval of the active ingredient in PHA-52 (for interstitial cystitis), and the absence of another effective treatment for head injury, leads the Company to reasonably anticipate that PHA-52 will enter clinical trials at the end of the safety testing stage (phase I) or at the beginning of the safety and effectiveness testing stage (phase II)."

pharma21.net

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Therapeutic uses of DMSO from Pharma 21...

pharma21.net

pharma21.net

pharma21.net

Jim