I would really like to know who complained to the FDA. A competitor? Disgruntled employee? Someone looking to make money off of shorting the stock? I would say it is almost certainly the last one, but also possibly a disgruntled employee. It is not like this materialized out of nowhere, because the microscopic particles do not seem to have had any impact on product safety so far (8 years).
"the FDA reviewed a report completed by Sientra and found no particulate matter on Sientra breast implants"
If this sentence is taken at face value, this is saying that the FDA itself found no particulate matter. Perhaps there were actually microscopic particles found in that case, but nothing big enough to cause any alarm.
Shkreli did not do anything to AVXL. He only shorted like what was is, 100k shares? Come on.
Plus, he isn't trading KBIO so he hasn't made any money off it. (that's illegal since he became an insider after taking control...)
There are thousands of biotech stocks out there. I don't like AEZS because management destroyed shareholders. I don't care about CANF enough to buy it yet. I don't like AVXL because management is promotional and shady.
I like Sientra, Zafgen, Aerie, Geron, Arrowhead Research, and Exact Sciences, among others.
One more note... maybe they didn't mean that the FDA actually did an inspection but that they bought some product and inspected it. However, I see no evidence to support this right now...
Did some more digging. The FDA has a database for this. I don't believe that the information in the article is quite correct. There was an inspection in March 2013, and none in the spring of 2014. That puts the rest of the article into question.
Replace "DOT" with ".".
Here's another piece to the story. On The Street, in an article by a Stifel analyst, Jonathan Block, he is quoted as writing, "The last FDA inspection of Silimed's plant took place March 2013, at which time no 483 observations took place."
It is forcing me to subscribe, etc.... anyway, that is definitely disturbing but not definitive. The FDA doesn't regularly communicate with the MHRA, so the FDA inspection in 2014 doesn't mean that they then talked to European regulators to get them to do a surprise inspection. I would like to learn more about that FDA inspection in 2014, but I can't find anything.
This might point more towards the idea that someone who has it "in" for Sientra and/or Silimed, first trying the FDA, and when that didn't work, somehow getting TUEV SUED to inspect the factory right after the secondary.
I saw the article title, but it was not freely available without signing in, etc. I will try to see if I can find the full version.
I think the major problem with this company is that it does not have enough exposure and credibility here. No pre-clinical numbers in the PR. And, of course, this is just pre-clinical, so it is not by any means a sure bet.