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Could “poor growth in the production vessels” result in the “rejected DS GMP lots” referred to in the 483?
As Dew has observed, Foley made a ton when Allergan acquired Zeltiq. https://www.spglobal.com/marketintelligence/en/news-insights/trending/y4nbdd8ed0ez39qr2nah2g2
Eyeballing this, looks like he cleared maybe $80 million.
https://www.sec.gov/Archives/edgar/data/0001415336/000120919117028606/xslF345X03/doc4.xml
So looks like he will land on his well-shod feet whatever happens with RVNC.
Re: Holding RVNC -- It's small comfort but the time will not be completely wasted, I assume the long-term open label safety trial for cervical dystonia (ASPEN-OLS) continues and is accruing data, so at some point, assuming that is auccessful, they will be able to file for approval for their first therapeutic.
That's an excerpt from the first finding, which is about
<<I would think either their testing protocol is deficient or the WCB was damaged or contaminated. Revance didn't have a answer to these problems. >>
The answer is a new line, which they initiated in May, no?
From the 483:
I didn’t see any ambiguity in when the transfer happened, it happened in the vesting date, October 13, when the withholding obligation arose.
From the filing:
1. Represents the number of shares withheld by and surrendered to the Issuer on October 13, 2021, to satisfy tax withholding obligations that arose in connection with the vesting of Restricted Stock awards ("RSA's") for 400,000 shares. The RSA's vest in three equal annual installments from October 13, 2019, subject to Mr. Foley's Continuous Service (as defined in the Issuer's 2014 Equity Incentive Plan) on each vesting date.
Fair questions but the old working cell bank (WCB) was past its expiration date and a new cell bank is being “qualified.” Not there yet , true, but 1c refers to a protocol for manufacturing and qualifying the new cell bank. So its not like they are in uncharted waters, rather, waters that may be too rough for current management.
Not my area of expertise but it’s my understanding that an element of insider trading is misappropriation somewhere in the chain of knowledge, and information obtained from a FOIA request is perfectly legal. This article summarizes the law as of 2016. https://www.lexology.com/library/detail.aspx?g=d0a1cd90-7a5a-4aed-bbff-8a244af84411
I hope you are right. I should have known not to be happy about the OCUL news and stock movement, the Biotech gods were getting ready to FGEN me again.
Indeed, if the findings were communicated to them on July 2, or in any event, months ago, how could they suggest the inspection was routine, or whatever the equivalent word Dew focused on?
Got to be. And some of these findings look fairly serious. E.g., “the current manufacturing process is not the process proposed for licensure.”
<<The original question delt with the comparison of having been exposed to Covid versus obtaining the vaccine.>>
In fact, your original question was
In fact a Bloomberg article at 1:37 today (https://news.bloomberglaw.com/ip-law/abbvies-allergan-sues-revance-ajinomoto-over-rival-to-botox) at first reported that Allergan was seeking an injunction but the article was later corrected:
MRK results are pretty impressive, quoting from the WSJ article you linked:
If you go through the COVID-19 vaccine schedule process on the CVS website, you get to…
“I need to schedule an extra dose. I am fully vaccinated with Pfizer or Moderna and have a weakened immune system —OR— I need to schedule a booster. I’ve been fully vaccinated with Pfizer for over 6 months and am 65 or older; a resident of a long-term care facility; I am 18 or older and I have an underlying health condition putting me at high risk for severe COVID-19; or I am 18 or older and at high risk due to occupational or institutional exposure.”
It's mildly interesting that they are doing this as an amendment to the EUA for the Pfizer vaccine even though they have granted it full approval.
Appears you are correct, Amarin is cutting the sales force TO 300, not by 300. From the press release:
Consistent with this model, Amarin will optimize its U.S. field force and focus on the most productive territories. This will result in a reduction of Amarin’s U.S. field force to approximately 300 sales representatives who will remain a critical part of the Company’s commercial strategy going forward. Amarin will reinvest the realized net savings towards its expanded educational and promotional efforts.
The details of the FDA inspection process are new to me, but you stated,
The comparison between vaccinated and previously infected arguably suffers from some amount of survivorship bias - those with immune systems least able to fend off the virus don’t survive it. There’s no such selection with vaccines.
And you can even give it to one of those donor advised funds and keep a measure of control over the gift - you “suggest” a charity to them in the future and the generally follow your wishes.
Cannot wait to long, a gift after the merger vote happens and there are no contingencies will be treated ad a sale followed by a gift of the cash.
Maybe they can make hydrogen from natural gas, use it in fuel cells to power their plants, and recover the water exhausted by the process. Oakes will probably favor that
As they can by buying back stock. Indeed, the PFE dividend yield is about 3 percent.
Of course, that’s not without risk but in moderation…
Correct, Modeerna showed a small reduction in effectiveness, from the report DOC328 posted:
Hydrogen isn't so clean (not a surprise to Oakes and others here, I'm sure).
Thanks, you are correct, the ChAdOx1 nCoV-19 vaccine (67 percent relative efficacy in the article) is AstraZeneca. That makes me happy as I was vaccinated with the Moderna vaccine. The large difference between two mRNA vaccines didn’t make sense so my error was particularly foolish.
There are some overblown statistics in that article:
Sorry, was that supposed to be based on reality? I couldn’t help laughing at the charging animations, particularly the one that lifts up the car by the roof and magnetically charges it like a iPhone.
FGEN - I considered selling before the FDA docs posted but didn't - win some, lose some. The drug is approved in a bunch of places and is selling, if it keeps selling, there's value at some price even if it doesn't get approved in the US.
1. How hard is it to pronounce Roxadustat?
2. How hard is it to take yourself off mute when its your turn to speak- for the fourth time?
3. I admit, those are quibbles, the main pain was the substance, which the FDA briefing documents foretold - but trading was halted when they were posted.
Adcom is a complete disaster for FGEN. 13-1 against approval in non dialysis, 12-2 against approval for dialysis dependent patients.
I’m just hoping that wine cellar in his new house is not a metaphor for the company - all hat and no cattle (all air but little wine).
The stock is now trading around $28, a bit less than where it traded on at the close on May 25, before news of the scheduled inspection was released. I suppose that the stock suffered less than it might have on the long period of news about the inspection being postponed to an unspecified time, so one might conclude that the market always assumed that the inspection would happen "soon."
RVNC is up 6.66% as I write this (a moderate reaction, in my view) but EOLS is up 5.4% as well. I would have said the RVNC news isn't good for EOLS but I didn't see any EOLS specific news. Maybe just a volatile stock on an XBI up day.
That's a lot better than I feared.
Speaking of inspections...
Here is the first half of a Bloomberg article:
Dipilumab has had some success, I know someone in this trial https://clinicaltrials.gov/ct2/show/NCT03359356 who got the placebo, crossed over, got the drug and had basically complete hair regrowth.
The article is reporting on this GAO report. https://www.gao.gov/products/gao-21-409t
I haven't studied it carefully, but this paragraph is of some interest:
Maybe this is naively optimistic, but with vaccine supplies looking to increase in the near term, perhaps FDA plant inspectors can get vaccinated and get back to work.
The proposal would not apply to those in poverty -- i.e., those with income less than $1 million. Timing capital gains into a year when your income is under that amount would also work -- unless and until they lower the level.