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Biotech / Medical : Pharmos (PARS) -- Ignore unavailable to you. Want to Upgrade?

To: Madharry who wrote (1173)	1/17/2001 11:09:23 PM
From: Filbert	Respond to of 1386

The way Pharmos is doing their clinical study is required for FDA approval. The FDA requires proof of performance before it will approve a drug for general use. There is usually a comparison with placebo, and sometimes a comparison with whatever the standard treatment is for the condition in question, (especially if the company knows that its product is better). One of the reasons that there are so many centers is that it is difficult to get subjects for the reasons that you are concerned. If you personalize the issue, one of your loved ones has a serious head trauma injury and needs to be treated, are you willing to allow them to test a new drug on your loved one? For a lot of people the answer is going to be "no", but for some folks the answer will be "yes". Every drug or device that has been approved by the FDA over the years has gone through this type of testing, so people do say "yes". One of the reasons that there are so many subjects is that the company needs to get a representative data sample, and a statistically significant data sample. The company has to prove that the product not only works, but how it works within gender, age, race, etc. classifications. The number of subjects required is sort of worked out with the FDA beforehand partly. The FDA does NOT tell a company what the study should be, but the FDA will provide "guidance" or "suggestions" as to what testing they would like to see, (I don't actually know what buzz words they use, but basically the FDA is obviously not going to guarantee anything. They expect the company in question to prove that the product works.) Phase III studies are extensive studies that are done to prove product claims. Whatever Pharmos' present claims on dexanabinol, they will have to be proven in the clinical study. This is the other part in determining the "proper" number of subjects in clinical studies. If you've ever done experiments of any sort, the larger the number of samples, (provided you have a "representative" sample), the smaller your error bars generally, the "better" your data is or the more you can see in the data. With a large data set, it is easier to see trends in the data, and hopefully justify the claims that one makes for an outcome. On the flip side, the more subjects one runs, the more expensive the study, and Pharmos isn't made of money, (as we shareholders well know). So, in my not-so-humble-opinion and my experience, I think that Pharmos wanted to do the Phase III studies themselves because they think that dexanabinol has a chance to be a superior product in the treatment of head trauma, and by completing the Phase III trials themselves and proving the drug is superior, they can make more money from the pharmaceutical firm with whom they eventually partner. The risk is: are the trials planned sufficient to get data that will lead to FDA approval? If you want to see what can happen if not, look at the trials and tribulations of SCIO (Scios) from 1998 to 2001 as a primer.

To: Madharry who wrote (1173)	1/17/2001 11:37:58 PM
From: wolfdog2	Respond to of 1386

madharry, I think you are focused on the wrong problem with regard to PARS. Management is very experienced. They have gotten two products successfully through the FDA and have a third on the way. I wouldn't worry about their design or ability to pull off a P3 study. The problem with PARS, imo, is that the results of the study are a considerable way off, success is not a sure thing (statistically there is about a 20% failure rate) and interest in the stock is likely to flag until the P3 study nears completion. On the other hand, the stock seems very cheap given that they do have two products in the market, a third which should be approved in the near future and a deep pipeline in addition to dexanabinal. So, the risk as I see it is stagnant money. Of course, had you bought when I first mentioned the stock to you, you would have almost doubled your money by now. Perhaps not so stagnant after all. <g>

To: Madharry who wrote (1173)	1/19/2001 11:01:56 PM
From: Cacaito	Read Replies (1) \| Respond to of 1386

1. Phase III could be successful with as little of 300 patients, to ensure statistical significance (not just a trend) with a lower % difference 900 patients is a more sure way to do so (and more expenxive). 2. If I remember well, Quintiles the biggest CRO of the world (contract research organization = administration of all clinical aspects, fda, European union regulation, clinical centers, statistics and logistics for about $8,000 per patient usual fee). 3. Phase II in humans showed patients with close injury benefit the most, so probably there will be stratification dividing trial in close and open injuries and maybe even three if hemorraghic vs non hemorragic, and it means that will need practically 4 to 6 groups of patients, two or 3 placebo groups and two or 3 treatment groups. Very complex. 4. Many centers, many countries, many different clinicians take away "CENTER NOISE" where some place "always gets it right" and some place "never gets is right". 5. Many centers is more expensive, more approval needed from Ethical Committes, more logistics complications, but also more rapid patients accrual, cause many inclusive and exclusive rules applies (usually about 20 or so each). 6. Ethical approvals are different in different countries, easier in Europe than US, some European countries need only "institutional approval" aka Big Brother approval. In the US is almost certain that family or subject will need to approve participation in trial. 7. Big pharma wants to get 90% of everything, and pay 10% of nothing. Small biotechs most struggle for financing in the markets, privates, venturers, convertibles, bonds, and finally big pharma goes in. 8. Aviv got the money, if success, big pharma will have to pay big, some $30M to $50M and 50%/50% royalties division. 9. The market is "institutional" aka distribution to hospitals,emergency rooms, ambulance companies, state of national health departments (cheaper and easier up to a point)as compared to pharmacies/physicians marketing (needs big pharma almost invariably). So Pars could go alone a long and highly profitable way. 10. Big pharma does not equal success, look at SGP big caca in Zona, J&J in Ergo, Bax in xoma (up to now, maybe later they get something but so far terrible), and this are just some of the mistakes, they are many more. 11. Big risk anyway.