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Replies to post #239371 on NorthWest Biotherapeutics Inc (NWBO)
08/13/19 3:03 PM
Not if the FDA decides, instead of approval or outright rejection, to issue a complete response letter.The Dreaded CRL: That is a BIG IF that will totally floor ALL the longs here; especially True LONG TERM LONGS steeped in studying FDA's trials re CRL; the interim results posted and authored in JTM Abstract by 69 leading immuno oncologist/neurosurgeons from leading medical institutions and defy what CEO Linda Powers has down in the last two years to keep NWBO afloat! Hard to argue that the FDA abused its discretion by issuing such a letter if it can raise legitimate questions. And that is not difficult to do. The FDA has wide latitude and even though a CRL will delay things indefinitely, the FDA has a right and even a duty to do so if it has questions/concerns.
NWBO's silent strategy could backfire and embolden the FDA to do so.(NWBO CEO Linda Powers purposely and strategically has rightfully REMAIN in this realm of SILENCE IS GOLDEN: Very very few here has understood what I pointed out beginning in late 2015 to this day: namely that I advised NWBO very early on it was totally pointless to have a PR WITHOUT a crescendo or tidal wave tsunami of them as AdamF and his deep pocketed nefarious forces would as history has demonstrated quash the positive short term impact of a PR from NWBO, Thankfully CEO Linda Powers did see the rationale and did accordingly. AND it was no small feat that despite ALL the ongoing litigation, NWBO was victorious in every single case despite the planned strategic diversion of BOTH occupying/draining management time and precious scant resources. Although a shareholder ONLY is aware of this SILENCE, NWBO given it's physical proximity to the FDA's OCER is in FULL COMMUNICATION with FDA's OCER via the following:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-pdufa-products-guidance-industry
https://www.fda.gov/media/109951/download
) NWBO is rather unknown and has little leverage. Did Beau Biden, John McCain or Susan Bayh(who was on the NWBO BOD) avail themselves of DC VAX L? IMO, not likely.
Why NWBO cannot even defend itself against a poly-sci major who has done a great job creating FUD and battering the share price. That happens to 90+% of tiny BioTechs especially those pre FDA Ph 3. Reading a score of Larry Smith's Smith on Stocks (SOS)elaborate reporting will elucidate. . This is not lost on the FDA.your speculation is rather imaginative and spurious Anyway, the FDA is a political animal and has its bread buttered by much more powerful and influential interests than NWBO.
How does NWBO deal with this? Silence is definitely not the answer.Silence has been in place by NWBO since early 2016 and it IMHO is unlikely to change ESPECIALLY at this VERY LATE STAGE waiting for TOP LINE . NO amount of shareholder pressure no matter how many tens of millions of share one owns IMHO will dissuade IMHO CEO Linda Powers resolve: funny how BSB and Umibe expected both the dethronement of CEO Linda Powers along with sale of NWBO and instead it was landslide voting with no exceptions in the last Proxy along with the Huawei Sawston sale instead of NWBOStellar results and/or a partnership/BO. At this point, I think many shareholders would be happy with a buck or two BO and call it a day.It does NOT matter what shareholders will be happy with since there is basically 0% institutional ownership. What matters really is what price CEO Linda Powers deems acceptable! Going it alone is a long, uncertain and highly risky road. JMHO.
WBO's silent strategy could backfire and embolden the FDA to do so. NWBO is rather unknown and has little leverage.
AI
