i have flatulence watching this stock trade ...psti up nicely, vblt up nicely, alny surges, blue up nicely, sphry doing great, kite bought for premium ....and psdv? more of the usual ..continued downward spiral ............. at least alim hanging in there .....mz. lurker, pls wake up - have a cup of coffee or something - take some no-doze ...your stock is tanking ...do "something" ..
Does anyone know? Under the new terms in which PSDV receives income from ALIM, will that not be credited to their earnings until the 2nd quarter instead of the present quarter?
The trading setup for PSDV looks very enticing. awe-som*sto-cks just allerted a new stock - it beats having to dig online yourself for new stock ideas.
As a very long term shareholder of pSivida, I've seen evaluation agreements come and go. They leave the room only after years of "nothing happening". It is never announced that they've left the room. I recall P. Ashton speaking of potential partners with Tethadur on his last conference call...yeah, the next day he was fired. So, is it possible that the "pending collaborations" are ghosts of Christmas past? You bet. But we are all hoping that Nancy is bringing more focus to pSivida management. And lets face it, the Durasert platform has two very good indications in the books that will take market share from large pharma drugs. More importantly, the combined MC's of Alimera and pSivida are still less that 150Million; that's pharma chump change. I'm hoping that pSivida finds a way to partner up with OA Durasert and sells off it's Durasert ophthalmology gig with an Alimera acquisition. I'm not sure how to value Durasert OA, but my guess is that it's going to work very well, much like micro-dosing chronic and difficult to treat diseases of the back of the eye. We will get some news on that by the end of November or early December. Perhaps with a collaboration agreement to boot. I have many regrets about holding the stock of this company. If I only sold all of my holdings with every pop, then purchased it all back after it's inevitable fall......I would have been in much better shape than I am today. The evaluation agreements have yet to materialize into collaboration agreements. Let's hope that changes with the one year anniversary of Nancy's and Deb Jorn's arrival. This MB has been dead for these reasons, we're all kind shell shocked.
An Oncosil Pancreatic Cancer Clinical Trial #NCT03003078 was started in March 2017 and is scheduled for completion in February 2020. PSDV has an 8% royalty and an annual $100,000 license maintenance fee. Its curious I wasn't able to find any mention of Oncosil at the PSDV website, but it has been included in the 10-K's. I understand that in the past PSDV has sought to downplay the potential of Oncosil.
Although we've received zero information on the pending PI Hospital for Special Surgery implant that delivers Dexamethasone for severe OA. I am intrigued by the potential regulatory pathway that may accompany a potential filing with the FDA. Dex is well understood by the FDA as a drug used in OA. It's injected in the knee with limited success in patients, as it just doesn't last very long, like 30 days or less. So, an implant for severe OA delivering Dex on a sustained ( 1yr.) basis might be well received by the FDA. I find the initial PI trial by HSS curious. There are only 6 patients in the initial study, small to say the least. So, is it possible that the FDA and HSS have recognized that should the SR implant be effective (and HSS is the investigator sponsor) , perhaps the regulatory pathway may be simplified. Dexamethasone is a well understood, off patent drug. Perhaps an expedited 505(b)2 pathway was considered by HSS and pSivida from the outset of the implant. In this pathway, data from all previous regulatory filings may be used to bolster a new application. For those that have not heard of this FDA pathway to approval, it's good to review it: The 505(b)(2) application is one of three established types of new drug application (NDA), and it is a pathway to approval that can potentially save pharmaceutical sponsors both time and money. However, many sponsors are unsure how to evaluate the possible benefits of using this type of application. The 505(b)(2) regulatory pathway is defined in The Federal Food Drug and Cosmetics Act as an NDA containing investigations of safety and effectiveness that are being relied upon for approval and were not conducted by or for the applicant, and for which the applicant has not obtained a right of reference. These applications differ from the typical NDA (described under Section 505(b)(1) of the Act), in that they allow a sponsor to rely, at least in part, on the FDA’s findings of safety and/or effectiveness for a previously approved drug (the “reference drug”). Section 505(b)(2) was added to the Act in 1984 with the goal of avoiding unnecessary duplication of preclinical and certain human studies. However, the sponsor must still provide any additional preclinical or clinical data necessary to ensure that differences from the reference drug do not compromise safety and effectiveness. The 505(b)(2) NDA also differs from an abbreviated NDA (ANDA; described under Section 505(j) of the Act), which is an application containing information to demonstrate that the proposed product is identical to a previously approved product. Identity is proven in an ANDA simply through chemistry and bioequivalence data, without the need for preclinical and clinical trials assessing safety and efficacy. In a sense, a 505(b)(2) application can be thought of as a hybrid that contains more data than an ANDA, but less data than an NDA.
This was a very strong conference presentation. The biggest call option on the stock that could make this a 10 -20 stock is, as one analyst noted in the Q and A is PSDV osteoarthritis product. And she was very positive about the scoring method and when the IND data will come out. People did not dig deep, and in a week or two once they do this stock can really skyrocket. Also, the CEO said she is positive about securing additional partners this year, and is already on the hunt for it plus positive news coming on the key trials.
SPHRY up 16% today ...over $9 and change ... bought more shares today to increase my position ...positive news on cancer front for this little known Australian stock...market cap now close to $350M ... I posted about it previously when I t was $5 and change ...check it out ...as always, do your DD ... it's my largest position ..I like it's odds .... as well as the successful vivagel ph III results that they announced earlier ...glta
After market high was 1.56, a short's attempt to paint the tape with small trade at 1.19 notwithstanding. Most trades are between 1.40 - 1.50. Will close above 1.50 tomorrow.
Hey, Mzzzz Lurker, -you forget that you work for shareholders -pls do us all a favor and sell PSDV to ALIM -
PSDV reports earnings on Monday. Any positive news should move the stock higher. No new news means we will continue to go sideways until FDA filing is made. I am hoping for new news but will continue to wait at these low stock price levels. Glad to pick up more shares cheaply if sellers try to push the stock down again based on no news.
Quickly get out why you can. I could barely stand to hear the conference call. The shorts are piling in to drive the stock to zero. Whoo is me.
Tick tock timer
FDBL had 100 million shares traded in under 30 minutes today.
Still a waiting game for positive stock price moving news. Will it be this reporting period (in 10 days) or the beginning of next year? No doubt that FDA submission will be reported by January 2018. Possibly we could hear of another collaboration effort. We are building a nice trend up off the recent lows. The almost 3% short interest is going to have to pay up big when the stock soon begins to move. Not a lot of stock to trade available when they try to cover.
Hmmmm? Could we have hit the lows for PSDV? Are the shorts scrambling yet? I tried to buy all I could get at close to a buck a share. Not a lot of sellers were trying to get out at those levels (low volume).
A reminder that in less than 3 weeks, PSDV will deliver an earnings report. Generally, they like to provide positive accomplishments and news that hopefully this time will move the stock to a higher level.
To put things in perspective, less than 1% of the shares are trading. This small amount of trading is not confirming a negative price trend that I am concerned about. If large amounts of sellers were bailing, then I might pay attention. I keep putting in buy orders at these low prices and much of the time I only get partial fills. Tells me sellers are reluctant to give up at these low levels.
Short interest is up for no reason. All news is positive and just a matter of time before price moving results are reported. Nothing for me left to do but keep buying at these low prices and wait!
SNOA (MC $23 M) (Cash $13 M) Shares Out: 4.3 M / 17 FDA approved products some of them are in early launch phase plus additional Product launches expected within 6 months / Profitable in 2018 = 1000%+ UPSIDE POTENTIAL..GLTA
Sonoma Pharma (Nasdaq: SNOA)
Market Cap: 22.1 Million Cash: $12.6 Million Price: $5.15
Driving to commercial EBITDAS breakeven, without dilution
Grow current product portfolio with all sales people
•Alevicyn HydroGel, Dermal Spray & Spray Gel for atopic dermatitis & dermal procedures •Celacyn for scar treatment •Mondoxyne for severe acne –launched late 2015 •Ceramax for skin repair in atopic dermatitis–launched in April 2016 •SebuDerm for seborrhea dermatitis –launched in November 2016
Launch 3 New Products –our product pipeline –one every other quarter
•Launching Loyon–Fall 2017 •Ceramax in foam and gel forms –Q4 2017 & Q1 2018
Launch and Grow New and Current Products: During fiscal year 2017, we launched four new dermatology products, including SebuDerm™, Ceramax™, Lasercyn™ Gel and Lasercyn™ Dermal Spray, bringing us to a total of eight dermatology products for the treatment of atopic and seborrheic dermatitis, scar management, surgical procedures, severe acne and “state of the art” skin repair technology. We also obtained three new FDA clearances, now totaling 16 overall. Our strong intellectual property portfolio consists of 63 issued patents and 33 patent applications pending.
We plan to launch our new FDA approved product Loyon® (a skin descaler currently marketed in Europe) in the upcoming months and have a strong product pipeline of several product line improvements, including a line extension of Ceramax™. All in all, we believe this could possibly be our best product line of new FDA approved dermatology and skincare products yet, and we believe our innovation plan will help lead us to profitability.