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I've had the opportunity to watch attorneys who could knock it out of the park in action. I don't personally know LP or Les, but I do know their credentials and have watched their efforts in regards to NW. They both strike me as being very capable of going yard. I will say IMHO in the public domain and here online LP gets marginalized due to her prior affiliations, and to some extent because she is a woman who is an attorney (for the board IMHO is bolded eventhough opinion is tempered). Saw some savy investors who didn't get out in time get burned by Denderon which soured my appetite for this space. In regards to Cognate and knowing the infastructure costs to start up IMHO (not bolded hopefully less controversial) LP aligned silent partner(s) to back NW via Cognate at time when I would not have touched NW.
Yes, but go back a while and NW started in Seattle.
Certainly seems to have a put lot of pieces in place. Going back 20+ years there have been 3 biotechs from the Seattle area I've followed and considered investing in - the three being Immunex, Denderon, and Northwest. The best investment of the three to date would have been Immunex and the worst Denderon. Jury is still out on Northwest, but there is no shortage of conjecture. Immunex was the precursor to Denderon when Immunex was acquired some of Immunex peopled started Denderon and their previous success gave Denderon immediate credibility. Denderon provided proof of concept as well exposed weakness (costs) in immunotherapy. I did not invest either Immunex or Denderon. I am in Northwest and I kicked the tires a long time (much longer than Koman) before doing so.....
Hello Schnauzer1,
You are correct biologic production is new and expensive especially for large scale clean room type facilities. For a little perspective I've pasted a post from last June BMY is spending nearly $2bil to establish production on 2 continents in a little over 10 years.
Know-Fear Sunday, 06/21/15 11:58:35 PM
Re: None
Post # of 40611
What level of investment required to establish biologics production on two continents? For BMY it's nearly 2 billion dollars and their second facility won't be operational until 2019
Bristol-Myers Squibb to Build Biologics Plant in Ireland
Pharmaceutical Company Expects to Invest About $900 Million in New Facility
By
Michael Calia
Nov. 14, 2014 6:30 a.m. ET
0 COMMENTS
Bristol-Myers Squibb Co. on Friday said it plans to build a biologics plant in Cruiserath, Ireland, as the pharmaceutical company expands its global manufacturing presence.
Bristol-Myers said it expects the cost of the new plant to be comparable to the roughly $900 million it paid to build a biologics facility in Devens, Mass. The company said it expects to finalize the cost of the new plant during the second half of 2015.
Bristol-Myers said it expects about 350 to 400 scientists, engineers and other staffers to work at the Ireland site once construction is completed. The company projects the facility will be operational in 2019.
The move comes as biologic medicines are being used increasingly to treat major diseases, the company said, adding that the drugs make up more than half of its research-and-development pipeline.
Ireland has become a hot spot for the pharmaceutical industry, as U.S. companies have sought to expand in the country through so-called inversion deals that lower tax bills.
Write to Michael Calia at michael.calia@wsj.com
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Woodford investment fund filed a 13 G/A today. I'm not able to get copy at present and thought someone else might be able to review.
TC, Thanks always good to know your take. Also reassuring to think it's likely Woodford could find the office without a driver.
My questions might be interpreted as leading (they are) so I should acknowledge other firms reduced and/or exited their position in NWBO. And as pointed out by several overall institutions continue to accumulate.
TC, Not the oracle nor is this a rebuttal. Rather would like your professional insight on these firms since Woodford's analysts are allegedly a little shallow in depth of their research. In your opinion are most or all of these other firms equally well staffed with analysts? Would the normal rigor (dd) performed by these firms include perusal of the various investor message boards for new information? (Noting TGW by all accounts found the "temporary halt" in Germany) And to substantiate or debunk any new information found on said Investor boards?
TZOR hold off for now. Need to get back to my laptop and retrace my search.
Do good are you referring to post 39883? I think Koman is presenting a hypothetical example.
EU site cannot be updated by sponsors due to the software bug. PR would not be advisable when the site would still state "temporary halt".
As opposed to the broader market? Not much looking good right now. I am happy to see you back as you are generally a harbinger of better things.
Saw that too after your post last night. The EU site is frozen @ 7/31 due to software bug. So clinical trials is the only forum to update site status for Germany. Could be they are throttling back on sites to ensure the right mix between age cohorts and to top off enrollment at 348. Logical to do this in Germany as they've been lagging and probably have capacity.
They could forgo the confirmatory trial with a fully enrolled main trial and with the 300 already enrolled its plausible they have enough through screening to achieve full enrollment. Form the information you and RRR uncovered it appears Germany was the last site to halt screening. And Germany being slow to ramp up probably has capacity to add additional participants if they were needed.
As long as I'm throwing out plausibilities. Would the DMC be more likely to recommend AA knowing the trial will soon be fully enrolled? And could LP have her trial completion and AA too?
It is plausible they throttled back on sites with Germany being last to suspend screening. Easier to manage one site after they have confirmed data from the others to ensure their count is correct. If needied to keep one site screening Germany would be a logical choice being slow to ramp up they've probably not exceeded capacity.
I'm good. Knowing their litigious nature I was being careful not to besmirch their character...admittedly way way too careful in acknowledging attributes that most likely don't exist.
The gallantry displayed by these law firms in their nobel efforts to solicit plaintiffs has been and continues to be a classless action.
The 80+ heads being added at Cognate are pure overhead and won't be "enriching" Cognate's bottom line unless they are producing product. 80 heads is quite an expansion outside of NW with "L" is it feasible that any of Cognate's other customers/partners could far enough along in trials with another labor intensive biologic product to be produced? 80 heads just smacks of commercialization.....
Mav, more a question for the board than for you. Thanks for the reply to my post vacation question about the screening halt possibly signifying full enrollment as I was certain it had to be considered by the rational faction and I didn't have the patience to weed through the irrational posts to find the nuggets.
It's not the heat its the humility......a suitable prescription
Welcome back (in a reliable contrarian indicator way).
Thanks for the summation. I've been on vacation with no phone, cell, or TV and just now skimming over a smattering of posts from the past week+. Did see last Friday's PR and forgive me if this has already been discussed but couldn't the recruitment suspension simply be a indication they potentially have enough participants to fill the trial (without stating the trial is fully enrolled prematurely)?
Agree too. Simply put Pfizer article out as following up on what I stated I'd do and not as pump (hopefully a little levity). Did think it timely as Woodford states in recent article that new fund has possible acquisition targets and Pfizer is playing catchup. Beyond CI collaboration RK recently and I think Flip previously raised the possibility of Chemo in trial with Direct. But as stated by LP and more recently laid out by Bosch a CI collaboration is the more obvious direction.
Here's the link to article where Pfizer CEO states they are on the prowl for new acquisitions which I referenced in post earlier this week.
http://www.biospace.com/News/pfizer-ceo-on-the-prowl-for-new-acquisitions/385943
Pfizer has a sizable wad (cash) and as noted in the article not afraid to wip it out dropping $17bil on a acquisition in February.
First thought upon seeing the 400K is something got lost in translation. (Admittedly the first thought is partially attributed to AF so it is lacking in merit). Second thought is perhaps kinks have not been worked out from a liability perspective for early access. Second thought is pure supposition on my part I'm certainly not up to speed if early access limits liability. If not then it may be part of the rub along with capacity constraints.
You're going to make the other market timing savants look bad if you continue to make accurate real time calls....
Doc, Not hitting below the belt. Any softness implied or otherwise was purely from a future earnings perspective for Pfizer.
Very refreshing. Also confirms Beach's suspicion of L's capacity constraints.
Saw article recently where the CEO of Pfizer stated they were on the hunt for more opportunities in this space. (When I have time I'll see if I can find and post a link). Guess Viagra can't keep things pointed in the right direction for perpetuity.....
A lot is owed to the trial participants in the evolution. Hopefully both vaccines will be approved so their participation won't be for naught
Beach, well said. Both L and Direct have evolved. Most recently being method B for direct. And since method B is to be used exclusively in the phase II trials perhaps we will learn more about it's genesis. My opinion is the melding of automation and technology into the production made B attainable. Not to mention automation should ensure high quality for this personalized vaccine (greatly reducing human/lab variables).
Shorts are getting antsy
Thanks. I thought the points made by those well versed in financial disciplines were equally salient.
CFO could be a big addition if they get industry insider it would further validate the science and business model.
To put it mildly it could be an interesting afternoon......
Didn't Woodford sell last month?.........Dude is asleep at the switch.
In biologics there is more art to the science. Unlike mainstream BP where upon a drug patent expiration any pharmaceutical entity can simply start manufacturing their version of the drug and no trials are required. In biologics what amounts to a phase III trial is required to prove another entity can accomplish the art of the science as its not as easy as simply copying a formula or patent.
In regards to GBM we are saying the same thing. Peace.
Exclusivity can and most likely will in this instance provide protection beyond the patent expiration. The protection is limited to the orphan designation.
NW will have exclusivity for 7 years via orphan designation. Patent expires 20 years from filing date.