NorthWest Biotherapeutics Inc (NWBO)

[maverick_1]

Circumspect FDA:

My direct experience with the FDA as it relates to AMRN's VASCEPA made me highly circumspect as profiled below about the so- called impartiality of the FDA.

That added to the credence of why CEO Linda Powers had the strategic foresight and wisdom to do DCVAX L in three other countries!

It began with my self initiated online journey into the FDA labyrinth when the FDA claimed AMRN's VASCEPA was NOT a New Chemical Compound. I explored the FDA database that convinced me that THE FDA is INDEED BIASED!

maverick_1 Sunday, 08/14/16 05:39:56 AM
Re: Rkmatters post# 69778
Post # 69782 of 228564
SUING THE FDA..RKMatters et al: Here is a very recent example of how behind the scene lobbyists of BigRX short circuited an emerging biotech Amarin (approved Marine trial) in rescinding it's SPA for Anchor trial and NOT granting NCE over the last few years. Amarin took the very risky strategy of suing the FDA in two separate high profile cases. IF Amarin lost it's biggest disruptor biologic Vascepa under the Marine trial approval would have drastically limited it's current market and under the Anchor trial (18K patients to access 1/4 of the population dealing with folks who take Statins and having >150TG levels) that has been ongoing since 2011 would have been curtailed due to lack of funding. I took the risk of owning AMRN since around $1.

Lots of articles to read to expand one's mind in how the Biologics division of the FDA can be exceptionally difficult to deal with given huge special interest parties have a lot to lose and their internal FDA connections. I haven't read many of these in this search:https://www.google.de/search?q=Amarin+case+study+of+why+sue+the+FDA&trackid=sp-006

BTW: take a look at the disparity between large pending offering price in AMRN of 21 mlns shs@$2.85 a $55 mln deal vs since announcement: the premium!, re your comments. Everything is relative to each specific issue and not black and white. See ARGS post of mine

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=124511771

The only poster who bought AMRN from the above post was Mapman! in the high $1's!

That journey convinced me of the clear biases of US's FDA and allowed me to significantly add at the worst of times to my AMRN position.

The FDA’s credibility has been badly damaged by the opioid crisis amid accusations that at times it behaved less as a regulator overseeing the pharmaceutical industry than a business partner of drug manufacturers. The agency helped unleash the epidemic two decades ago when it approved the sale of a high strength narcotic pill, OxyContin, as safer and more effective than other painkillers on the say so of the manufacturer, Purdue Pharma, and without requiring clinical trials. Since then the FDA has approved other opioids for wide prescribing even as evidence mounted the drugs were addictive, open to abuse and often not effective for long-term use.

By sheer happenstance I met the now infamous Opioid Epidemic "posterboy"

https://www.npr.org/sections/health-shots/2019/03/26/706848006/purdue-pharma-agrees-to-270-million-opioid-settlement-with-oklahoma

Dr. Richard Sackler in the late 1980's where we both lived with real estate holdings.

Purdue Pharma despite ALL the litigation costs in 2018 made $5 Billion AFTERTAX.
Purdue Pharma is threatening EVERY pending legal lawsuit that IF it does NOT settle on Purdue's terms they will get NOTHING:

The reason why iMHO is that the Sackler family has their Billions ALL IN TAX HAVENS!

DIFFERENT STROKES FOR DIFFERENT FOLKS