looking at improvement in vision
Socaljewel, thank you for your appreciation.
Your are asking me what profession I am in. I am not a reseacher, not a doctor, not a professional investor (and not interested into the financial results of Genaera), not a lawer, not a patient seeking for a cure for this debilitating disease, ARMD. Do you have any guess? I will only tell you that I have been involved for more than 15 year into medicals devices an pharmaceutical industry, mostly focused into drug delivery devices which are more and more complementary to drugs. I also think that ophthalmology is one of the hotest field in medecine now, obviously because of the aging of world population and induced costs of caring and treatments of these old people.
You are interested about other drug that are on my watch list:
Well, see my post #212 where I give a list. I will add to the list Genvec with their interesting APEDF phase I trial, even though I am concerned with potential immunitary reactions for that approach.
I have posted on this great board (thanks to Dew) several concerns about what I think are the 2 best canditates today (Squalamine and Combretastatin). First concern is side effects (see my posts 212, 259, 361) in the long term. The fact is that I don't believe in miracle drugs. I do understand the excitement about these 2 drugs in view of the results, but history has taught us that it is always followed by a list of counterindications. For example, see Aspirin or Asthma drugs. For this last one, asthmatic people, treated on a daily base for the long term develop several intolerances. In the same way, the toxicity from the long-term use of anti-angiogenic agents is an important issue.
That is why I think any drug shall be studied with an adapted drug delivery device to limit potential side-effects, even if they are unknown today (4 months data is very small). That is especially true for the eye. Why treat systematically such a small organ. Everyone needs to be cautious about the optimism about the novel drugs in angiogenesis. The systemic administration of these drugs is not the ideal way of treating ocular angiogenesis, as the drug does not reach the target tissues at an optimal concentration.
Another question concerns the release date of data from competitors. My guess is that Lucentis data will be released at ARVO 2004 in May (see my post 378) and will give slightly better (or less worse) results than Macugen. Concerning Combretastatin, my guess was to have some interim data beginning of next year (see post 256). Yesterday, an insider post on Yahoo board for OXGN caught my attention (see #26659), it could be a rumor but this guy gives enough precision and I think it confirms Oxigene trial is well on track, so I maintain my prediction. Last point I would like to adress is about recent posts about accelerated approvals (see recent Katie&Dew posts). I quite agree with Dew, there is no way FDA will agree with a fast-track approval, for ARMD is not a life-threatening disease, it is not (anymore) a rare disease, and Squalamine is injected systemically. FDA people are professional pharmacist and the reviewers will never accept to accelarate the process. It is sad for people who are loosing their sigth but that is the rule of the game. If you don't believe that, just imagine the contrary, they accept and discover one or two years later potential problems during what is called the Phase IV or post-market surveillance...Another thing, Katie, where did you read that "Squal has without a doubt surpassed Visudyne in safety and efficacy"? I would be glad to see the data about that.
Once again, thanks again Dew for the idea of this HQ board and be sure I will appreciate all your comments about my comments.
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