I have learned in Biotech land, to always remain very cautiously optimistic. If you expectations are realistic, you will be able to handle the interim/update data as they roll in. It is not like we are awaiting a binary development. However, any positive developments will be very welcome. It has been quite quiet for a while. However, a surprise is always nice!
Amen to that. Mid year NDA submission cannot come soon enough. Once the NDA is submitted, I am hopeful for an expedited AA type approval. None of this six to nine months #$%$. If they cannot ascertain all the submitted data in 3 months or less, after already two delays....something is very wrong with the system.
You may be correct on that specific example, it has been too long ago for me to remember. However, most of the others in both classes mentioned, were totally independent with no sharing of revenues/royalties. In fact, Accupril was the 9th on the market and totally independent.
There are many classes of drugs that have similar, if not identical MOA's For instance, ACE inhibitors for hypertention/CHF. .Many different ACE Inhibitors are currently available. Though these drugs have different names, they are all the same type of drug, and they work in an identical way. ACE Inhibitors all end in -pril. Some commonly prescribed ACE Inhibitors include:
At one time in the early 2000's, there were 11 ACE inhibitors (Brand names), all concurrently marketed by several companies. A 10% market share for Accupril (Quinipril) was considered stellar. The same goes for statins...i.e.Mevacor, Zocor, Lipitor, Crestor, all have the same MOA, they all inhibit HMG-CoA reductase- but coexist in the open market. How is this dispute any different. As Bionerd explains, their are notable chemical differences and pharmacodynamics and pharmacokinetic differences. Even though all of the ACE inhibitors and Statins target the same enzymes, with the same MOA, their absorption, excretion, metabolic properties and distribution are all inherently different. All drugs have varying AUC's, Tmax, Cmax metc... Also, differences in dosing, toxicity, study outcomes. Most importantly is the human response via safety and efficacy. These two drugs are far more diferent than the examples I've sited. Even doctors often refer to the previous examples as "ME TOO" drugs. "Etep and Dris are very different. I am not a patent expert, but how is this any differnent from the previous examples? TIA
Good for you. Sounds like you are riding on house money for now. Defiantly makes it easier to sleep at night. RNN was very interesting when it spiked to 1.60 or what ever, I too took some off the table. There has been very little noise from this company, and does make it difficult to hold when there are other opportunities abounding. I am solid with what I have and will not chase the moving bio tech ball.
I remember when ICPT was boring at 40 pps, then in 2 days went to 500 pps. Bio techs are boring, until their not. If you have done your DD, boring hopefully, will be your biggest short term frustration.
I have been long for six years. Added at 7.20 the other day. Dr. Chan is relentless and passionate about his company. It is a great long term stock. You must be desperate.
Brandi Roberts, CFO bought direct (open market) on 3/26 and 3/27 for an average pps of approximately .50 cents. Say what you may, but it a good bode of confidence when management puts their own skin in the game. Albeit, only 38K, it is definitely better than insider selling.
Unfortunately, I admit I am still here. Been holding for two years. I am starting to feel like a bag holder. 1..2...3 Go for it bashers!
Cytokine storm is implicated in a number of disease states, many unmet disease states. The low float is creating a retail driven panic sell mentality. With the number of trials that are ongoing, imagine selling your shares when a breakthrough cause and effect data set is released. For instance, the rabdomyalysis trial. This can still go lower, and you may or may not get lucky on timing. You can argue long term, that today should not be selling, but accumulating. The bashers are relentless and always seem more convincing when a sell off like this occurs.
Hi Jet...Happy Easter my friend. Appreciate all of your posts. I am long RNN, but have started to look at MACK. I almost pulled the trigger in the 8's after some insider buying. Their pipeline seems robust. What do you think of MACK? TIA
The transition to Ed Kaye may play out to SRPT's overall advantage. It will be interesting if we get a new CSO in the next month or two. Also, possibility a partnership on one of our platforms (influenza ?). Perhaps even a BO offer, even though I do not want that. One thing is for sure, the last two years have certainly illustrated bureaucracy over benefit....medically speaking (especially when it comes to innocent kids with an unmet disease state)
Jet. Hope you are doing well. Thank you for all of your excellent DD and contributions to this board. I always look forward to your posts. For anyone out there that questions his genuine analysis, I will back him 100%. He has always prefaced his posts with speculation and risk, as all bio techs are vulnerable to a variety of risks. However, I am here as a long due to 3 potential compounds and a preclinical pipeline as well. Jet, if you could elaborate on the value of the discovery platform (as this is outside my league), I would appreciate it. Take care my friend....KGR
We have a highly productive discovery platform that continues to yield a portfolio rich in potential first-in-class and best-in-class compounds. Our discovery platform features small signaling molecule discovery (TIMES), computational predictive modeling (3D-GOLD) and nanoscale drug targeting and delivery. Working in concert, these technologies enables us to screen, select and optimize large numbers of compounds while retaining stringent selection criteria.
TIMES Platform (The Inhibitors of Multi-Expression Signals)
A discovery platform of small molecule inhibitors of multiple signaling molecules
In treating cancers, the combinational use of multiple cytotoxic drugs significantly increases the types and severity of harmful adverse reactions that patients experience. To address this issue, we utilize compound screening technology to streamline the drug discovery process prior to laboratory experimentation. Rexahn’s proprietary TIMES small molecule signaling technology has enabled us to discover more than a dozen targets involved in cancer proliferation. Using TIMES, we can more efficiently develop compounds with significantly increased efficacy and decreased undesirable side-effects.
3D-GOLD Platform (3D-Gateway Of Ligand Discovery)
A discovery tool of computational predictive molecular modeling
3D-GOLD is an integrated computational modeling tool of 3D-finger printing/pharmacophore, 3D-QSAR/proprietary QCID, 3D-ligand constructs, and 3D-dockings, that helps to predict the structural activity relationship of molecules using 3-dimensional models. 3D-GOLD is actively working to help Rexahn discover novel lead compounds. Leveraging this system, we are able to more effectively develop predictive models, formulate and test hypotheses for optimizing efficacy and increasing drug safety and bioavailability early in the process of drug discovery.
For more details, please refer to the QSID scientific article (Park DS, Kim JM, Lee YB, Ahn CH. QSID Tool: A new three-dimensional QSAR environmental tool. J Comput Aided Mol Des. 2008).
Nanoscale drug targeting and delivery
Development of innovative nanomedicines with higher efficacy and lower toxicity
In collaboration with nano-technology leaders, Rexahn is developing cutting-edge drug delivery systems that could increase bio-availability while minimizing adverse reactions. These technologies are based on nano-liposome and polymer encapsulation of existing medicines, an effective strategy to prolong drug action among other benefits.
dozens of new kids receive(d) and will continue to receive ETEP over the past few months and over the next few months, and there is obvious recognizable improvement, you will see 20 Christine's knocking on the FDA door. The parents testimonials (as conceded as an important FDA consideration), will trump this debacle dystrophin data, back into the pits of the labs, where they are being arrogantly scrutinized by a group with no idea of a true "Bulls Eye" methodology for reproducibility and validity. Even at that, SRPT's dystrophin analysis and assessments are as good, or better, than any comparator/competitor out there. Ten more mom's witnessing any form of early efficacy response, along with the safety study confirming minimal side effects, will make this dystrophin dynamic, a dramatically diminished Data point.
LOL I will pray for you my Beloved Pearsby, but it will not be for your business endeavors, rather for your mental health. And if you are truly married, an enormous and special prayer for your wife!