Let's all take a step back and think what is happening - the FDA - whose watershed event in its history is the fact that it
denied Thalidomide approval in the 's, is about to approve that very same drug. If you were them, wouldn't you be excessively
careful, maybe even to the point of paranoia, to ensure that EVERY possible thing is done so that this drug, which appears to have so
much promise to help those with horrific diseases, does not cause a birth defect in the future. This is why it is taking a little
longer. The company is being prudent in not talking to ensure they don't piss off some one at the FDA - in fact it is a good
possibility that Celgene's low profile has been requested by high level FDA executives - especially during this period immediately prior
to approval. Patience,patience - it will be AMPLY rewarded. Approval is coming in the next couple of weeks. This is just the
beginning of a series of positive events and a steady rise upward in the next couple of years. This stock could be over $50 by the end
of 1999. Patience.
Stocks usually move in anticipation of a news event. Celgene does not act as if something is about to happen.
Doesn't the whole world know that the moment this drug is out there CELG is on the map. All indications are that this should happen by end of this month. Should'nt the volume kick up?
Why doesn't this stock act like all stocks?
I hope we can have the last laugh on this one, "all the way to the bank"
The way it usually happens is Celgene will be notified 48 hours prior to the FDA's approval. The FDA issues the statement. Celgene then will issue a statement possibly followed by a conference call.
I believe in thalidomide's potential for antiangiogenic uses, especially for cancer treatment, and I have positions in both CELG and ENMD because of that belief. And to hear of its possible benefit for psoriasis sufferers? Maybe there's hope for my affliction and my messy jacket collars - and I can make money too?!?!?
Thalidomide for psoriasis?
With more and more news coming out about this notorious drug, some members are contacting the NPF to ask that question. The
answer is no for the time being. However, thalidomide, a drug that made headlines for causing a number of severe birth defects in
the 1960s, is making a comeback. A federal Food and Drug Administration (FDA) panel recently recommended that the drug be
approved for use in patients with a special form of leprosy, and it is being studied for use in various other inflammatory and
The majority of the FDA�s Dermatologic and Ophthalmic Drugs Advisory Committee voted that the benefits of the once outlawed drug outweighed the risks for people with
erythema nodosum leprosum, which affects about 50 percent of people with leprosy. Some researchers are betting that the world is now sophisticated enough to understand the downside of thalidomide and take advantage of its possible benefits. In the 1990s a number of people use powerful drugs such as acitretin for severe psoriasis with strict pregnancy restrictions (see �Soriatane provides new treatment tool for severe psoriasis,�
July/Aug 1997 Bulletin).
Then and now In 1962, thalidomide was withdrawn from the world market after deformed children were orn to mothers who used the drug during pregnancy. It had been widely prescribed as a sedative and as a treatment for morning sickness in Europe, Canada and Japan. Thanks to the skepticism of the FDA�s Frances Kelly, M.D., Ph.D., the drug never gained approval in the U.S. and the laws regulating drug approval were tightened.
Thalidomide remained unapproved in the U.S., but it was never ignored by researchers because of its ability to suppress the body�s natural production of a substance called
tumor necrosis factor (TNF) alpha, a chemical mediator. According to the FDA, serious infections such as tuberculosis, sepsis and cancer cause the level of TNF alpha to rise, which may contribute to the clinical detriment of patients. In cancer patients, for example, TNF alpha enhances the wasting process. Leprosy patients may deteriorate because of high levels of TNF alpha.
Areas of interest
In addition, researchers are interested in the fact that TNF alpha appears to inhibit the
growth of new blood vessels (a process called angiogenesis) to feed growing tumors. This
could prove useful in diseases such as macular degeneration, which results in the
overgrowth of new blood vessels in the central portion of the eye�s retina, where focus is
controlled. Both TNF alpha and angiogenesis are areas of interest for psoriasis
Thalidomide also may have the ability to combat aphthous lesions in the mouth and
esophagus caused by AIDS or other disorders. It also has shown promise in treating
glaucoma and lupus, as well as graft-versus-host disease, a deadly complication of bone
marrow transplantation for cancer patients.
Celegene, one of four U.S. manufacturers of thalidomide, believes the drug has many
potential uses. The company is also studying thalidomide analogues, versions of the drug
that retain its effectiveness without its toxic effects.
Strict control sought
Manufacturers, medical ethicists and researchers are looking ahead to a distribution plan
that would limit risks. It would include mandatory counseling of patients, strict birth
control measures and a stringent tracking system of users.
The NPF will continue to monitor the development of thalidomide and its analogues,
particularly if clinical trials for severe psoriasis or arthritis are announced..
I don't think the FDA gives a hoot about investors of a stock. Most likely the FDA will announce, when they want to without picking a particular time to do it. It is possible that CELG will first be notified by the FDA & CELG will actually make an announcement before the FDA.
In either case I believe the stock is not acting like investors are expecting anything to happen soon. Therefore when the approval does come, it could send a sonic BOOM through the stock, & new believers willcome out of the woodwork & send Celgene to the moon, Finally.
Our time is here NOW.
enmd is now at 15 1/2. i told you it is way ahead of celg and now the market knows it. stock is going to 18 near term according to lehman brothers report. also as i have mentioned look for deal with johnson and johnson on ihp product soon.
ENMD will never be competitive with Celgene. It is understood that if ENMD ever does get Thal approval, celgene will
distribute it- FDA won't want more than 1 company doing it. The fact is that Orphan drug status means that IF and WHEN a company gets
approval, no one else can get it for 7 yrs. ENMD is TWO YEARS away from any approval, Celgene is probably TWO WEEKS away. Celgene had
the option to acquire ENMD and passed and Bristol Myers walked away from ENMD because they realized off label use of Celgene's
Thalidomide will benefit from anything ENMD does because Celgene is so far ahead in the approval process. It is important enough to
repeat - ENMD is 2 YRS away - Celgene is 2 WEEKS! Celgene is about to rocket higher!