NorthWest Biotherapeutics Inc (NWBO)

[maverick_1]

Longfellow re: This is exactly what Novocure are doing.Using a device with a broader application (such as in GBM) as a Humanitarian Device.
Which is exactly what you are not supposed to do.
These Humanitarian Device Exemptions are supposed to be for very rare populations, hence the lower evidence threshold and now the permission to profit is supposed to encourage the development of devices purely for that rare population.

But the FDA guidance page on this has gone missing in action.



Now you can make a profit and the limit has been doubled to 8000 a year..

A perfect fit for Novocure, even more so when they get Medicare reimbursement (75% of MPM sufferers)

maverick_1 Saturday, 12/27/14 01:53:23 PM
Re: None 0
Post # of 238594

WRAPUP on GBM device (approved for rGBM in 2011) and halted
for efficacy,FDA approval 11/14 for newly diagnosed GBM) renamed Optune by Novocure:

Salient Points to Consider:
1.Only 3-4 mos better PFS
2.Monthly ongoing costs of $20K (SOME insurers cover it)
3. Greater than 18 hrs/day wearable application w/6 lb portable battery BACKpack with shaved scalp. Can one drive a car with it?, set off screening alarms@airport due to lithium ion batteries.
4.BUT HAS 150 centers in US SMSA areas for training, installation etc.

FAQ pg:http://www.optune.com/resources/questions.aspx

Privately held (by MDT;JNJ;PFE and two venture funds) but may be going for an IPO given the pulse of the IPO market (beginning with 1/12/15 JP Morgan HC Conf.... JP likely lead underwriter should it take place.)

For the above, there will be a market of demand, just a question of how large given the relatively small PFS improvements; ongoing costs (on lease!);level of personal obtrusiveness/convenience; receipt of CPT code for reimbursement considerations.

Key Facts from NovoCure http://www.novocure.com/
Founded in 2000
$250 million in development dollars
Over 200 employees in 6 countries
More than 150 global treatment centers
21 peer reviewed publications
More than 1,690 patients treated

NYTimes article:
http://www.nytimes.com/2014/11/16/health/electrical-scalp-device-can-slow-progression-of-deadly-brain-tumors.html?smprod=nytcore-iphone&smid=nytcore-iphone-share&_r=0

Special Note: been aware of Novocure for 6 mos.

IMHO the massive influence of MEDTRONIC as the KINGPIN of ALL medical device companies PLUS the clearly influential DRUG KINGPINS Pfizer and JNJ:

ALL THREE are responsible for what LongFellow95 points out IMHO

SAME can be said about the MASSIVE influence of Sean Parker’s Cancer Institute upon NWBO since 2016!

DIFFERENT STROKES FOR DIFFERENT FOLKS