It seems like complete insanity to run these ads while the FDA is on the cusp of changing the rules for TV ads. TV ads may likely not need any of these disclaimers at all -- only disclaimers for 'Serious AEs'. Probably about the very worst timing for any TV ads ever, IMO.
Great idea. If O does not kill patient immediately then keep giving it to the patient.
As for efficacy: efficacy has been proven to be no better than existing industry standard drug which does not cause O-induced horrific suffering and deaths.
Let me remind everyone that a search for a magic explanation of O deaths is not merely 1.5 years old. No, it is closer to 4 years old. I will state again very truthfully that of the four original phase III trials, two of them were for non-dialysis patients. Those two studies showed O-related deaths.
Naturally, T&A wanted O to be approved for this (larger and more lucrative) population. They also had no way of knowing that FDA would (tragically) accept O on any level, given the O-related deaths. Therefore, T&A frantically attempted to determine the 'root cause' of the O-deaths approximately four years ago. That effort was not successful. Any reasonable person must conclude that O itself is by its very nature a Killer Drug which can't be explained away or 'fixed'. Thank you as always for reading and understanding the truth.
"Scientists from DOE’s Argonne, Sandia and Livermore labs, as well as UC Berkeley and the Lawrence Berkeley National Lab, traded remarks with representatives from industry and venture-capital firms, including Flextronics, INFINIUM, FuelCell Energy, Applied Materials, Inc., Alcoa, Inc. and Lockheed Martin. One topic of discussion was a proposal to create public-private partnerships to speed time-to-market for new technologies emerging from university and DOE labs."
Thanks GWP! Great info.
I hear you about never investing in this sad company. I agree, even in the 20 cent range, the extreme likelihood would be that one would lose all of their investment.
Maybe my view is overly influenced by observing PCYC emerge from 'sure death' and to resurrect itself over a multi-year process. They had one drug which had absolutely no chance (but no lawsuits to my knowledge). However, they ended up acquiring two new drugs somehow for peanuts and the rest is history. Still not sure how that really happened --- but I am left with the impression that these biotech companies are first and foremost financial vehicles for insiders/Wall Street to make money.
FDA will not require that in the future. Maybe they wanted to get that out there to public while they still can. You never know.
Wrong. You are deluding yourself when you think that finances are completely meaningless for pharmas and that they do not have comparable values in the market. This false belief holds up when times are good but not when a realistic market sets in. The falsehood of 'this is biotech so we will hit a home run and so finances don't matter' is great if the home run is hit. But otherwise, cold, realistic finances set in when lenders want their money back. They will not allow $70 million to be thrown away much longer.
Look at Income Statement and Balance Sheet. This company burns $70 million per quarter. That is completely absurd for a company of this size. They burn $11 million per quarter on interest payments alone. So, each quarter $70 million out the window.
As for the balance sheet, since Q1 is finished, they have about $330 million in assets (I do not count phony 'Goodwill' and 'other assets') and $430 million debt.
OK, so not only are they under water by $100 million but they are burning money like there is no tomorrow. Something must give. A market cap of closer to $700 million seems way too high. Even if there was not such an outlandish cash burn every Q, I would put market cap around $300 million. Given the cash burn, I would put the market cap about $200 million as the true market value. This corresponds to about $1 per share fair market value.
Recent MF article is evidence. They have not done DD. They do not get it.
Garp, you should worry more about your own biotech investments and less on educating us on how everyone-involved-in-fuel-cells-is-good-besides-FCEL-even-though-fuel-cells-themselves-are-not-cool.
I agree Yankees. I would point out that you even give GE too much credit by calling them a 'visionary company'. I refer all to the very origin of GE. You allude to the Rockefeller days but the actual players were JP Morgan and the infamous Edison/Tesla rivalry.
We should all know by now that Edison was wrong and Tesla was a total genius and was right about AC power. In a nutshell JP Morgan used his money and power to destroy Tesla and basically wrench away the patents from Tesla/Westinghouse. This was/is the very essence of GE. Tesla was destroyed and GE is fabulously wealthy to this day. Their very nature is this way.
So, yes, we should be extremely wary of GE, especially because they have branched out into so many other avenues, such as buying media corporations, etc. We are talking about trillions of dollars in play here. All dirty tricks will be utilized. Truth will be tough to find.
GWP -- question about impending BK:
I'm trying to imagine a scenario which would justify buying AFFY at around 20 - 25 cents. Seems to me that would not make any sense unless AFFY had already gone through BK. Would it be possible for AFFY to declare BK and then absolve themselves of all lawsuits? Would the stock still be traded or would it be completely de-listed?
I am trying to understand how AFFY would ever justify any sort of investment. It's hard to imagine. If there were some way for them to completely eliminate O from the company, along with the O-related lawsuits (not sure if that is even possible with BK) - then I could see a small amount of value in an existing shell company with absolutely no assets or liabilities. The value would be in the fact that it is a publicly traded company already with a presence on the markets and uber-pitchman Orwin-san lurking in the shadows.
Is there any way for LAFFY to rid itself of the humongous lawsuits and if so, what would that mean for AFFY the stock?
Thanks for any info. TGC.
Looks like some of the good posters from here have commented on the MF article and straightened the guy out. To the author's credit, he replied to the comments and admitted he made a mistake. I respect the guy for that - it is very, very rare for someone to admit a mistake in writing. So, I respect him for that. Will respect him even more if he writes a new article discussing MCFC and why there are no such limitations that GE claims.
Yeah, Motley Fool needs to read Bloomberg article.
In a way the video/article from MF is awesome because they basically say that the only reason that FCEL/Ballard are not awesome is because they need platinum/palladium -- and if somehow they did not need these expensive metals then it would be 'game on'. Of course MCFC does not need these -- so what they are saying (without knowing it) is that FCEL wins hands down!
I would encourage Eisai to pull this ad until FDA has changed the rules on TV ads. It is likely that they will soon announce change to rules which means scare side effects will not need to be mentioned. Why scare people with these ads at this time. Very bad timing IMO.
Correct. So why bombard people with scary side effects which will never be forgotten? Worst timing EVER for any ad. Once you drill into people scary side effects, they are not going to forget them just because they have later been omitted. Absolutely stupid timing for these ads.
Ironically FDA will likely soon announce a change to TV ads so these side effects will not need to be mentioned. smh.
Great info Sharon but HORRIBLE decision to air commercials now. 50% of commercial is scary warning to public. As I have said, FDA is in the process of changing the rules so that none of these will need to be aired. WORST POSSIBLE TIMING, IMO. Should wait for FDA to make announcement. Oh well, maybe some people will not be scared off forever. I encourage Eisai to reconsider. Maybe TV spots have already been purchased so they 'have to' put these ads on at this inopportune time.
Great info Dr. Ormani. I would have thought one might be safer than the other - but you're saying that there is no real difference between H2 and gasoline. Interesting. Thanks for the info.