i think you may be a little confused about some of the finer details of how it works. you're correct in the sense that the fda does ask questions about pma applications without issuing a not approvable letter. however, these questions pertain to things that are included in the application. that process doesn't allow for things that are not already included in the application. so, for example, the fda may ask for questions that would clarify exactly how the population was chosen for a study, and the company can answer those questions and the fda can move on. the fda may also ask questions about exactly how a particular analysis included in the application was conducted. however, the fda cannot ask questions where the answer requires conducting extra analysis that falls outside of what was included in the initial application. in those situations (which is exactly what happened with luviva), the fda issues a not approvable letter that outlines their questions and what needs to be done in order to answer the question sufficiently.
i've conducted a fair analysis of the warrants that were recently issued using both a trinomial model and monte carlo simulation. i derived values of the warrants at somewhere between $0.03 and $0.05, which puts the value of the recently issued stock around $0.18. if you then use this price to determine the value dilution impact on the stock at the date of the offering, it suggests a diluted stock price immediately after the offering of $0.217. of course, stocks tend to dip a little lower than what value dilution suggests shortly following dilutive events, and this stock did as well, hitting down into the low $0.21's several times since. could it hit lower prior to any positive news? absolutely. those that bought into the offering technically bought their stock around $0.18, and they could sell down to whatever fair value they assigned to the stock without taking any loss on it.
Luviva didn't fail to achieve statistical significance. in fact, the us trials were just as successful as the various other trials that have been conducted around the world.
this is what the company said in regards to the first non-approvable letter:
"In fact, in the letter the FDA said: that the statistical analyses provided “fundamentally useful information regarding the ability of the device to discriminate between (serious cervical disease) CIN2 and (more normal conditions) CIN1 and normals”. In addition, FDA did not indicate that the endpoints of the study were not met.
In the letter, the FDA requested additional clinical data on a newer model version of the LuViva device. FDA also recommended excluding adolescent women and women with ASC-H referral Pap tests from the study population, even though they were part of the original agreed upon study protocol. This could be as simple as a change in labeling or a request to reanalyze our data without these subjects."
this is what they said in response to teh second non-approvable letter:
"The FDA letter contained new questions pertaining to three areas of our amended PMA application.
1) An analysis requested by FDA and included in our amended PMA specific to a) patient follow up data and b) combining human papillomavirus test results with the LuViva result in a patient management algorithm.
2) Procedures related to the cleaning and disinfection of the LuViva device
3) A technical question pertaining to the optics of the device."
oh, you obviously fooled people.
by the way, there seems to be a common trend on yahoo message boards. if you make somebody look like a fool, they'll come after you with all of their multiple id's. if you make somebody look like a complete idiot, they may even create a new id to try to mimick you (like you did here). but, if you repeatedly make somebody look like a complete idiot, they'll even follow you around to various boards with those multiple id's. lol...i guess i repeatedly made you look like a complete idiot, huh? as always, i'm flattered that you STILL pay so much attention to me, and that you are so devoted to me. if you thought that you actually had half a chance in a battle of wits, i feel pretty certain that you would come out with one of your more recognizable id's and try to make me look bad. but, i think it's safe to assume you know you don't have a chance of doing so, hence your pathetic little game that you play. i guess you still don't have a life, huh? carry on.
i agree that the layoffs are an indicator of deeper issues. fundamentals strongly suggest this is more of a move to stay afloat than it is a move to become profitable and succeed. as far as the company ultimately ending up in bankruptcy with a debt conversion, i see the potential, but i'm not ready to agree yet. best case scenario is that there will be a debt free but fledgling company in about 7-10 years, if they don't become completely obsolete before then.
i have been in and out of the stock for about about a year and a half, and had been watching it for a while before that. i watch pending fda decisions, both nda's and pma's, and this came on my radar when they resubmitted in late 2012. i think they have a strong potential to get fda approval. i also think the product has the potential to be quite successful internationally. i need to see execution to stay in it. i have previously viewed the international opportunity as a nice hedge against any potential for fda rejection, but i'm not feeling so certain these days.
i'm curious to know how you started following in 1993.
albeit, the digital trend was still significantly lower than where i believe it needs to be to yield a healthy company several years down the road.
based on the way they worded some things yesterday, i am assuming they were in sales, and that's likely how the knew of the pending layoffs. it's also why i only giving limited credence to the ad sales comments....(1) there could a bone to pick and (2) there likely is not a full understanding of the accounting, meaning that he may basing his comments on something he sees happening, but he doesn't fully understand how it's all calculated in the end. but, then again, i did see a bit of a surprising trend in digital revenue this year.
i wouldn't be surprised...that wasn't a very smart move. i could tell they were definitely an insider based on how they discuss ad sales, but i believe they are likely in sales and don't fully grasp a few things. they were obviously correct about the layoff announcement, but i'm not sure what to think about the ad sales comments. if he is correct, you'll see the impact on the financials at least by q2 2015 earnings. you'll see it in at least one of the following...revenue (p&l), accounts receivable (balance sheet), allowance for doubtful accounts (reported in the caption for accounts receivable on the balance sheet) or bad debt provision (cash flow statement)....if he's correct...either 2015 vs 2014 yoy percent decrease in revenue will not track to 2014 vs 2013 yoy change in ad sales, or there will be some sort of trend change with ar, or you'll see allowance for bad debts increase significantly as a percent of ar, or, you'll see bad debt provision increase significantly. exactly which of those occurs will strongly suggest (1) whether he was right or wrong and (2) exactly what is misstated...just ad sales, or revenue as well. if they really went into an in depth scheme to cook the books (i'm giving the benefit of doubt and assuming this not to be the case), it wouldn't necessarily show up in any of those.
in case you missed it yesterday before it was deleted, you can still see the comments on the post if you select the "Messages" view..the post was "All Hell Breaking Loose Thursday ". you can't see the original post because it was deleted, and that's where they were mentioning that massive layoffs would be announced today.
"Today’s changes included planned workforce reductions and job reassignments through 2015 that will impact approximately 1,000 employees or 25% of the company’s employee base, including 350 field sales representatives."
somebody was on here yesterday (the post is now removed) saying that massive layoffs would be announced today. that part was obviously true, and they obviously had some inside knowledge. the other part of their post was a bit more worrisome. they were saying that the company had been overstating digital ad sales gains. if that proves true like the layoffs warning did, that could spell a bit of disaster for revenue next year. so far this year, revenue declines are in line with ytd 2013 ad sales declines, a pattern that is expected. between a/r, bad debt and revenue, i'm not seeing any signs of revenue being overstated at all...if correct, they were only referring to reported ad sales yoy percent changes. if true, it looks like it likely began around q4 2013 or q1 2014 and has persisted throughout this year. it will be interesting to see what revenue does over the course of the next year.
also....unless you're saying that deferred directory revenue and possibly deferred directory costs are overstated on the balance sheet, they haven't exactly cooked the books based on what you have said....unless they're also amortizing an overstated amount of ad sales into revenue. it just sounds like they have overstated digital ad sales in their press releases, which would create some invalid assumptions about future revenue...but, no cooked books.
they're definitely tracking ad sales differently than in the past if that's the case. in that past, it was ad sales in dollars ytd 2013, ad sales in dollars ytd 2014...calculate the percent changes, so what you're talking about couldn't even happen. in fact, the actual dollar amounts used to be shown in the 8-k's. now that they only show yoy percent changes, there's no visibility to the actual calculation, so who knows how they're actually doing it. they have only screwed themselves if this is the case, but it would explain why digital ad sales in 2014 have been a little higher than i anticipated.
so...if ad sales are reported correctly...you can safely assume that if there's a 10.9% increase in digital ad sales ytd 2014, you'll see somewhere around an 11% increase in digital revenue ytd in 2015. you're saying digital revenue in 2015 will grow much less than that due to this?
by the way...you probably shouldn't be mentioning this stuff here. regardless of whether it's true or false, you could put yourself in the hotseat.
"Books cooked with "Ghost BOTS". Laying off loss until 2015 and reported false gain for 2014."
not sure if serious, but what exactly do you mean by these two sentences, especially the second one?
as far as reinventing print..i wouldn't be surprised if that was the route the new ceo took.
fair game...you obviously don't have much more intention than being a troll, so putting each other on ignore is probably a pretty good idea here. speaking of knowledge regarding investments, maybe you can school me on secondary ipo's sometime. i noticed you deleted that post...i hope you did so because you realized how foolish you looked.
lol...nevermind the fact that i said i know it won't happen (more importantly, i never called for $5, or any other amount, as a price target), and that it was a pipe dream. in fact, i even went so far as to say that even if it hits $2 next year following fda approval that it would be "at extremely overvalued speculative multiples". never miss an opportunity to misconstrue, do you?
not sure why you consider toons my side kick.