Look at it from an investor's perspective. A week ago,we were waiting for results, expecting positive results and submission for approval. One week later, after results were released, we've been informed by lifetech that the commercialization will be delayed and another trial is required. So from an investors perspective, we've gone from waiting for results and then near term submission and approval to now waiting for device changes, another trial and additional dilution. If Lifetech is correct about a new trial, investors are not better off than they were a week ago. If Lifetech is wrong about a new trial, there is now added risk that the issues found during the trial could results in a rejected device and still the need for a new trial before resubmission.
Thanks...I'll have to go listen to the call, as that's in conflict with what lifetech released...Lifetech doesn't seem to go out on a limb, but is explicit on the need for an additional trial and even reference Echo's expectations of a Q3/Q14 release. I
" Of particular concern, IV acetaminophen (as used in ICU) interfered with the Biosensors and as a result, 3 patients were excluded from the trial. While management believes they have identified a solution, this is a known issue in the field and would hamper the commercial prospects for the Symphony system. The result is that Echo Therapeutics will be required to make all the fixes and perform another clinical trial. Assuming that all the fixes work and the trial is successful, Echo expects a limited launch of their Gen2 version in Europe in Q3/Q4 2014."
At their last offering, it was obvious based on cash burn that capital would be needed by year end or early Q1, i'm certain I posted this conclusion. Nothing's changed. They should take Platinum's suggestion and partnered instead of crushing shareholder's once again. How much can raise this time? How far will it get them?
Ace, where did you get your info? I haven't been able to find clarity on this. I would think some of the changes are being put in place, because they may be needed to mitigate an initial rejection.
Info for delay was in the proposed stock offering...missed that..I'm still curious as to what was said about this on the call.
The new offering proposed, appears to indicate they are rejecting Platinum's proposal. I suspect Platinum's proposal cuts salaries and management doesn't want that to happen, so they plan to go it alone at shareholder's expense.
How much will they get from this new financing? Will it be enough to be cash positive or will they need to raise cash again to launch Symphony next year? I suspect the later and the stock will be under $2 soon.
Has the information in the LTC report been released via other means to the public? I missed the call concerning the trial results, but there appear to be a 9-12 month delay before a product is available with additional trial costs. The company's press release had no hint to a delay. Did they hint to this on the call?
Was this a misleading statement by the interim CEO in the press release?
"We are extremely pleased with the positive results of this trial. Importantly, this was the largest study of Symphony to date and it was the first time that all of the components of the system were used together in a clinical trial. We believe Symphony demonstrated satisfactory safety, accuracy and reliability during the clinical trial to satisfy CE Mark requirements," said Robert F. Doman, Executive Chairman and Interim CEO of Echo Therapeutics."
He conditioned his statement with "believed" and semantically his statements are probably true to it's strict definition, but it sure leads investors to have the understanding that there would be no new trials". The question then comes as to when they knew device changes were needed, leading to a new trial and substantial delay.
Too bad they weren't able to raise cash at $4 as dilution is going to hurt at these level.
They are not losing each sale. They will be making money on LS and investing in a pipeline of 3 other potential products...so a net loss yes, but the idea with any growing biotech is to invest for the future.
Thanks...I was using rough ballpark numbers as COGS is relatively minor, but point taken and more precise numbers is appreciated.
To blame PP for selling is not correct. The latest Sched 13D/A shows they are not the ones selling (correctly stated by DDBUYER). I dont know the short's strategy and can only speculate. Shorts are probably banking on low expectations for LS and additional cash raise needed near term. But it's also possible they've begun covering after Q3 results. We'll know within the next two reporting periods, if that is the case. Most shorts have a profit, so you'd think they'd start locking it in.
$100M sales every q? i think you are off by a factor of 10. Cash Burn is $10M. Cash is mainly used for admin and development of additional pipeline. LS Sales of $40m (half current B&M market) will bring approx $20M revenue to Navidea and their bottom line or 5M per Q, cutting cash burn nearly in half.
Platinum put the 850,200 and 1,474,443 conversions into the PP Arbitrage fund..they were not sold. . Also consider the shares given to FPMI. In addition to these shares the PP arbitrage fund has been a net buyer over the past 60 days. They had significant purchase under $2, just before Q3 earnings. The did sell some in the upper $2 range, but overall, they were a net buyer. So Platinum has not really been a net seller, if you don't consider the FPMI shares. PP Arbitrage owns a significant number of shares.
The problems is financing and hence the sell off. More money is needed. We already knew it was needed but with trial results being delayed and FDA meeting being delayed, it could be financing is needed before any positive catalysts occur. If there aren't positive catalysts before financing, shareholders will get hit hard again, unless Platinum works some type of deal.
Scap that...I was reading the CAH agreement, but based on Q2 reporting, they recognize sales earlier and AR is less than cash, so I'm not correct here..
They get sales numbers 30 days after the end of the Month, and cash 45 days at the end of the month, so today's cash number should includes sales for May, June and July LS sales. Q2 numbers include no cash for LS, but probably booked as AR.
There could be other sources of cash. It was Sept last year that the NIH awarded a 3yr grant for RIGS. It's possible a second installment came in, total grant was up to 1.2M. You also have the two grants for NAV4694 totalling near 500,000 and they have a total of 4.1M...I doubt we reached additional milestones more installments already,but we don't know. So I suspect the grants may account for an additional 1M+