To: technetium who wrote (237) | 12/29/2022 2:40:51 PM | From: Arthur Radley | | | There had been no place to hide in biotech investing in 2022. Today’s report about th collusion between the FDA and Biogen and their Alzheimer drug isn’t going to help. How does it look for the numbers for those signed up for 2023? |
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To: Arthur Radley who wrote (238) | 12/29/2022 4:43:19 PM | From: technetium | | | Investigation faults FDA, Biogen for Alzheimer’s drug approval
washingtonpost.com
“The biotechnology company Biogen and its regulator, the Food and Drug Administration, worked in concert, ignoring internal concerns from the company and skirting the agency’s own written guidance, to allow the Alzheimer’s treatment Aduhelm to receive accelerated approval and hit the market at a cost to patients of $56,000 a year, according to a scathing report released Thursday by two House committees.
“The “unusual” collaboration, which resurrected Aduhelm three months after Biogen had canceled clinical trials, unfolded through at least 115 meetings, calls and email exchanges between the company and the FDA in a year, said the report by the Committees on Oversight and Reform, and Energy and Commerce.
“The joint effort climaxed with staff from the agency helping Biogen draft a document used to brief the FDA’s advisory committee before it met to discuss Aduhelm on Nov. 6, 2020. Although the FDA often follows an advisory committee’s recommendation, it did not this time. After no member of the advisory committee recommended Aduhelm, the FDA changed course, allowing Biogen to move its drug to an accelerated approval process.
“At the FDA’s suggestion, the drug was labeled for use by the nation’s more than 6 million Alzheimer’s patients, even though it had been tested only on people with early Alzheimer’s and mild symptoms, the report said...
“… Aduhelm proved to be a financial dud, generating $3 million in revenue for all of 2021.
”In a statement responding to the report, Biogen said it had cooperated with the committees and “stands by the integrity of the actions we have taken.” Biogen’s statement also cited the FDA’s internal investigation, which concluded that there was no evidence of impropriety in the dealings between the agency and company.
“Biogen stuck with the initial $56,000-per-year price tag despite projections that the drug could wind up costing Medicare up to $12 billion in a single year. Other Alzheimer’s treatments sell for much less. A year’s supply of Aricept costs less than $8,000; Exelon, a drug in the same family, costs about $8,800 for a year’s supply; and Namenda costs less than $3,000 per year...” |
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To: Steve Lokness who wrote (241) | 12/29/2022 9:09:36 PM | From: Arthur Radley | | | Steve, send him a PM. Hope all is well in your neck of the woods and you and the family had a great holiday. I’ve been reading about your area, the heavy flooding and power outage due to vandals. Tonight we are getting heavy rains sent from the west coast..we expect it will rain all night. Four days of sub-freezing temps and now 70 degree temps and local flooding. But we all know that global warming is a hoax. |
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To: Arthur Radley who wrote (242) | 12/30/2022 10:11:15 AM | From: Steve Lokness | | | <<<<<<But we all know that global warming is a hoax.>>>>>
We are use to rain and flooding here on the Olympic Peninsula but our recent tides were almost 2 feet higher than expected. Not inches - feet! By far the highest tide I have seen here at the house.
There will be a contest then? I have seen no messages - no hype. I'd like to enter after missing a year. |
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To: Steve Lokness who wrote (243) | 12/30/2022 12:22:26 PM | From: Arthur Radley | | | Look at the east coast of Florida the tidal erosion is eating away the beaches and next are the condos.
I have submitted my names and I think he plans to consolidate and organize the entries and then create the website. Sort of fun to see how bad one can do in a contest and this year I'm looking at most of mine down more than 50%---one is down 80%. |
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From: Aloner | 12/30/2022 4:56:18 PM | | | | My 2023 Picks. I believe I came in close to dead last this year, so, I'll be the first to post this year! You may want to avoid these as my track record speaks volumes... Thank you TECHNETIUM for all that you do to make the contest happen. Here are my 10 picks, all equally weighted.
AFMD 10% CDTX 10% CLSD 10% CRDF 10% CRIS 10% CRVS 10% KZIA 10% MGTA 10% MRNA 10% PRVB 10% |
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To: technetium who wrote (233) | 12/30/2022 5:58:17 PM | From: technetium | | | And at the wire …. it’s GENEGURU running away from the pack. A detailed report to follow.
GLYC came through at the end.
Now remember, you’ve got only a few more days to get your new portfolios in. Next year HAS to be better. Special offer, submitters of portfolios for the 2023 Contest can request a YTD breakdown of performance of the individual choices in 2022.
Thanks to everyone who participated in this contest.
Happy New Year!!
| Report Time Ranges
|
|
| From
| To
| Recent
| 12/23/22
| 12/30/22
| YTD
| 12/31/2021
| Index Performance
|
| Symbol
| Recent
| YTD
|
| ^IXIC
| -0.30%
| -33.10%
| ^NBI
| -0.12%
| -10.91%
| ^SPSIBI
| 2.71%
| -25.71%
| Share Performance
| Recent Change as % of Initial Price
| YTD
| Top 5
| Bottom 5
| Top 5
| Bottom 5
| GLYC
| 52.778%
| SNGX
| -29.27%
| MACK
| 193.09%
| GNCA
| -99.99%
| PDSB
| 42.346%
| AMRS
| -7.58%
| CABA
| 144.06%
| PLXP
| -97.95%
| MACK
| 27.877%
| RVNC
| -7.05%
| WVE
| 122.93%
| CLVS
| -97.00%
| OCUP
| 27.346%
| IPIX
| -6.00%
| FENC
| 118.18%
| ATHX
| -96.27%
| VKTX
| 20.652%
| DYN
| -5.55%
| CBIO
| 113.07%
| OTIC
| -95.81%
| Top Ten Portfolios
|
| Top 10 Portfolio YTD
| YTD(Portfolio - SPSIBI)
| Rec
| Rec(Port. - SPSIBI)
| Rec. Change Total Value
| GENEGURU
| 19.89%
| 45.61%
| 14.05%
| 11.345%
| $14774.05
| DIEGOSAN
| 2.74%
| 28.45%
| -0.27%
| -2.975%
| -$274.18
| MOPGCW
| -2.01%
| 23.70%
| 8.99%
| 6.277%
| $8079.59
| BMAZ001
| -11.23%
| 14.48%
| 12.01%
| 9.304%
| $9520.49
| TECHNETIUM
| -18.35%
| 7.36%
| 1.96%
| -0.751%
| $1568.15
| BRENDAN_49
| -20.04%
| 5.67%
| 4.34%
| 1.636%
| $3329.50
| BIO-TITAN
| -23.39%
| 2.32%
| 24.81%
| 22.097%
| $15226.73
| RAJU_BIJLEE
| -24.77%
| 0.94%
| 3.46%
| 0.748%
| $2513.83
| ROCKY9
| -25.80%
| -0.09%
| 5.19%
| 2.482%
| $3661.71
| TAMBORELLI
| -25.96%
| -0.24%
| 11.53%
| 8.819%
| $7653.70
| Average and Median Portfolio Performance
|
| Avg Recent
| Avg YTD
| Median Recent
| Median YTD
|
| $3,795
| -32.88%
| RAJU_BIJLEE
| $2,598
| JFM WINTER
| -32.22%
| 6.16%
| RAJU_BIJLEE
| 3.901%
|
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