Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Correction- This was Novum not Novitium.
Silvr, the Goods and service section on a number of trademark applications ANIP has submitted is as follows.
Silvr, that is awesome. Those taking the drug have already had a 64% increase in survival time over the average advanced breast cancer patient and the trail continues. These numbers will only get better over time.
Today was the second senior management team virtual presentation to investors as part of a non-deal roadshow in the last two weeks. Looks like management is now actively trying to attract investors.
Presentation
Someone more well versed in patent litigation may wish to jump in here. As I understand it, it looks like the Patent Examiner is ready to grant Novitium the patent for Hydrochlorothiazide Compositions, once they deal with the double patenting reasoning for the final rejection. According to the conclusion of the Final Rejection it looks like they need to reconcile their first patent application (parent) with this application to overcome the rejection. Simply filing a Terminal Disclaimer for the Parent patent application # 17/546,175 would render the rejection moot paving the way for their next submission to be approved.
The document can be accessed through the link below. Select Documents and Transactions, then go to the be conclusion of the Final Rejection.
Patent Application
Silvr, under Lalwani, ANIP has moved to an intelligence led approach which is best exemplified by their approach to Corti. I imagine they are well positioned and adaptable to the changes that are occurring.
JMHO
I think you are right on ANIP being able to leverage the US manufacturing advantage.
Novitium got approval for a generic Viagra (Sildenafil Citrate)
Approval
Brusselspirits, I agree with Silvr's assessment. It gives ANIP salesforce a good talking point about their stability.
Thanks North.
Silvr, according to the Orange Book, Elestrin's strength is 0.06% (0.87GM/ACTIVATION). This drug is 0.01% in strength.
Chemo Research has the only other generic version of Divigel
Being able to get transdermals approved should accelerate the manufacturing review, when they are advancing female testosterone.
Thanks auh2oman.
I agree Silvr, MNK is proposing reducing the Opioid Victim's Trust only $700 Million of the $1.7 billion settlement agreed upon in the first bankruptcy agreement. Ownership of the company goes to the creditors. With $1 billion at stake, this will likely drag out in court and I can see them being forced to sell off assets to sweeten their proposal. This assumes that they can still keep the plants running.
Silvr, though we can't authenticate the accuracy of the following post from Cafepharma. It looks like your opinion regarding MNK and Acthar is materializing.
Silvr, ANIP present at the H.C. Wainwright 25th Annual Global Investment Conference two days after the Hypertension 2023 Scientific Sessions. If this is where the Libigel trial data becomes public, it could be a very big week.
Scientific Sessions
Should be one of many to come auh2oman.
You maybe right, they don't have to report until they have done accumulating and could drag that out to their benefit. Another two big trades after hours today 47,800 shares and 63,778 shares.
Today trading 365% of 65 day average.
Silvr, just spit balling here, but all the selling in light of PPS likely in the start of a long climb, post trading restrictions from the offering in May, makes me wonder if the shares are being acquired by a future board member to replace Rob Brown.
I agree Silvr. Hard to believe it does not get approved.
Silvr, looks like the testosterone CV risk reduction articles are starting to come out. Here is the conclusion from "Major cardiovascular disease risk in men with testosterone deficiency (hypogonadism): appraisal of short, medium and long-term testosterone therapy – a narrative review"
Conclusion
What emerges from the current clinical literature is that, irrespective of the length of study durations, testosterone therapy provides significant health benefits and reduces risk of cardiovascular disease. More important is that data from many observational and registry studies, demonstrated that longer durations of testosterone therapy were associated with greater health benefits and reduced cardiovascular risk. T therapy in men with T deficiency reduces the incidence of major adverse cardiovascular events attributed to improving overall metabolic function.
Article
The author, Abdulmaged M Traish, of the Department of Biochemistry & Department of Urology, Boston University School of Medicine, Boston was also one of the authors from "International Society for the Study of Women’s Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women"
Article
Silvr, you might be right about a third party benefitting. Especially with 823,600 shares traded over the last two days with no news release, aside from earnings over a week ago.
A 69,081 share trade 10 seconds after the close today. Accumulation in big chunks?
A 200,000 share trade 8 minutes before opening of market and a 53,000 share trade at 74 minutes after close today. Looks like someone knows something.
Nice, dasgrunt. Looks like a separate sales team from the rare disease team. The 10 Specialty Pharmaceutical Reps being hired will be part of a newly created Specialty Pharmaceutical Team. Looks like initial focus will be Rheumatology.
It might be linked to an acquisition or an in-licencing deal.
Thanks for the link Silvr. Looks promising for Libi data.
With respect to the CC. I expect Lalwani wants to maintain a prolonged streak of beating analyst expectations and is purposely conservative in his guidance. Seems to be working, 4 quarters and counting.
GLTA
Thanks auh2oman.
BB, they will likely ensure that they key client's have loaded up before announcing an upgrade.
The CC indicated that they have yet to sell the Oakville facility. They did acquire three products from the Akorn Pharma auction. Still looking for product to leverage their rare disease infrastructure.
Only two analyst present and not very inquisitive.
Though they did say anything, next earning CXC will be after the October 27th deadline for Libigel trials results to be posted. Should make for an interesting 3 months.
GLTA
Thanks auh2oman.
Easka, I am not concerned. As you mentioned, Corti number will likely be good, especially as Mallinckrodt faces another bankruptcy. We should find out more about what the money they raised will be go towards.
GLTA
Thanks Silver. Looks like it marked the 10th anniversary of ANIP being listed on Nasdaq. Changing from BPAX. Don't know how many get to do it on their 10th anniversary.
Hopefully, Silvr. If not, I am sure they will be quizzed on it.
Looks like ANIP will have a lot to report in next month's earnings report:
- Product launches
- Updated balance sheet (including proceeds from selling Oakville plant)
- Akorn drug acquisition
- On top of most likely solidly beating analyst estimates on revenue and earnings
- Raised guidance for both revenue and EPS.
JMHO
Novitium picked up an approval for Potassium Chloride.
Approval
Looks like ANIP's was the winning bidder for some portion of Akorn's ANDA portfolio of drugs.
Aquisition
Good info Silvr. Hopefully they include testosterone.
I think they sold the Oakville plant. They were asking $26.2 million CAD for it and it is no longer listed. It was listed last week when I checked.
Interesting info auh2oman and silvr. Thanks.
Thanks Silvr. As I was putting it together, I too felt good about the long-term prospects.
That is encouraging. Thanks Silvr.
Same for you and your family BB.