Basically- a delay because it has to go through another agency for approval.
Echo Therapeutics reports $16.7M loss after Prelude delay
March 20, 2012 — 12:48pm ET | By Damian Garde
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About | Privacy | Mobile Edition TOOLS Subscribe Email Print Contact Author Reprint Philadelphia-based Echo Therapeutics ($ECTE) took a $16.7 million loss in 2011, a year in which the company had planned to launch its needle-free, transdermal drug delivery platform, the Prelude SkinPrep System.
But that launch didn't happen, thanks to a regulatory delay. Early last year, the FDA told Echo and its partner, Ferndale Pharma Group, that Prelude would need only "minor" changes before approval. Now, however, Prelude must clear the Health and Human Services Department's Combination Products Department, which has led to a protracted process and an unclear launch date, an Echo spokesperson told FierceDrugDelivery. In the meantime, Echo and Ferndale will pursue European approval for the product, according to Echo.
The company was in the red in 2010 too, losing $4.3 million, but had planned to start bringing in revenues by getting Prelude on the market in the third quarter of 2011. Echo's stock price has taken a hit, as well, dropping more than 50% from its June high of $4.50 a share.
Despite the Prelude delay, Echo brass is optimistic the company can generate revenues in the near future with Symphony tCGM, a wireless glucose monitor that uses the Prelude's noninvasive skin permeation to keep tabs on blood sugar levels in diabetics.
"We made very tangible progress during 2011, and we achieved some very important milestones," CEO Patrick Mooney said in a release. "... With a strengthened and simplified balance sheet and an experienced management team, Echo is focused on the continued, accelerated pace of product development finalization and clinical validation necessary for regulatory clearance of the Symphony tCGM System in both Europe and the U.S."
The good news is that things seem to be moving right along with Symphony. Echo announced in January that it's recruiting critical-care patients for another round of clinical trials of the monitoring system after raising $3.6 million for final development. The company did not say when it hopes to get the product on the market, however.
The only thing exciting about using the prelude for lidocaine delivery is that it will meet the licensing obligations for the prelude. I do not want to seem heartless but abrading the skin around an IV site is silly in my opinion. I would not expect it to be a significant market driver. However using a non-invasive realtime glucose monitor is exciting. It would be significantly easier to get approval for the prelude without the drug delivery portion. In other words get on with the approval for the Symphony tCGM. I would not expect that a external medical device that is not an implant would need to much further testing. After the initial excitement about Echo wore off, i am becoming increasing more skeptical about the longevity of this company particularly after reading the quarterly report. It is concerning to me that they want to eventually divest all production and sales. This is concerning because they do not have any other products in the pipeline.
If you had a chance to listed to the last presentation that was webcast you'll see that Mooney does not want to grow the company. He wants to sell it. He's not in this for the long haul and is doing the minimum to to sell it (IMO). He probably isn't prepared to put together a robust sales and marketing team.
I absolutely agree that Prelude isn't where its at...but the lack of Prelude puts into question management's ability to do its DD on the regulatory process (coupling issue) and possibility its ability to deliver...so I'm certain it weighs on the sp.
Thanks for sharing!!! The other agency was due a requirement of the coupling of a drug with the product....a lot different than the initial minor issues consistent with expectations or labeling issues. I hope the bar doesn't keep moving.
Additionally this below comment leads me to believe that Prelude approval and revenues are not in the near future...unless they meant in addition to possible Prelude.
"Despite the Prelude delay, Echo brass is optimistic the company can generate revenues in the near future with Symphony tCGM, a wireless glucose monitor that uses the Prelude's noninvasive skin permeation to keep tabs on blood sugar levels in diabetics."
in and out, forgot to tell you, if you read william o,niels book on stocks[editor of ibd] he says never buy stocks under $5.00 because the big funds and pension funds can,t buy under $5.00. they move the stocks.