I turned CBNC this morning and heard the news about Biogen waiting for FDA approval for their Alzheimer’s disease drug. I thought I take some risk, why not! and boy it paid off. It is quite unusual though, sort of let me AMC! Looks like it’s going to dip anyway!
Biogen has been trading under its fundamentals for quite a while as it’s drugs fall off patent one by one. This was a big win for them after 8 years of trying.
your right and even if they didn’t get the approval it wouldn’t move down so much as it volatility rate is quite low.
Quite funny, they get FDA accelerated approval for drug that costs 56k $ per year of treatment, without any proof it is actually working.
The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need. Approval is based on a surrogate or intermediate clinical endpoint (in this case reduction of amyloid plaque in the brain). A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.
Drug companies are required to conduct post-approval studies to verify the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial does not verify the drug’s anticipated clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.
So they give people drug which they might find non-performaning post- mortem. BIIB got around 8 years to do post approval study.m.
Also some interesting read:
It all smells of
It’s something like a lottery, investing in Biotech. The medicine R&D cost a huge pile of money and could produce a medicine that could be not approved.
The Biotech (related to medicines) are also subject to high political risk if they have high tag prices on their medicines.
If some people die or have serious side effects, the companies are also punished (like aviation companies or aircraft manufacturers with air crashes).
That brings high volatility and uncertainty.
And it smells more like s**t to me, I did a great move by selling my 4,100 USD shares couple of weeks before FDA approval
Probably would have done the same if I owned any shares on Biogen. The scientific consensus was that the new drug had no grounds to be approved yet. It was surprising that they got FDA approval.
That why I thought this Is like GME or AMC, just done by higher authorities, really funny, FDA trying their hand meme stocks LOL