The later the ADCOM the better for SRPT. More conformational safety data, more parental testimonials and supportive demand for approval, more musculoskeletal and cardiopulmonary data supported by dystrophin data and 6MWT and cardiorespiratory function data. Conversely, BMRN will get weaker with time and data, especially when standing side by side to ETEP. KGR
You could make the same case for Dow Chemical, Ford and many others stocks that were beaten down (2008/2009) to scraps. Dow Chem went fro 6 to 52, they had the same CEO and still there. The Macro market dynamics determined most of that, not the CEO. KGR
Awesome!! Like I said in a previous post, I could care less what the pps does between now and PDUFA. This is a major victory for the DMD families. ETEP will be the clear choice as more children experience it's pristine and effective treatment results for their horrific disease. Also, this is the spark to the other Exons being studied. This is absolutely awesome. Sorry I am so Giddy....14(AVII) years and holding. KGR
Nice multiple ID's My Beloved Devil. Either that, or kevin is your puppet (if you know what I mean)...since he responds in your favor within 1 minute on every post. Cowards have multiple IP's. Your Understandingly Sympathetically Sensitive to Insecurity...Beloved...Pearsby BTW.....Quits!!! Both your ID's are on Ignore...I win...haha
pps wise, Macro, Micro. Even if the market drags us down with an NDA acceptance. It is still great news long term. ETEP is advancing through all the necessary steps and can be a viable and effective treatment for the DMD children. Block out the pps tomorrow. Good, bad or indifferent. It will be great news for ETEP, SRPT and the DMD families. That is what we all need to focus on. JMO KGR
Is almost a no brainer to me. They are saying, "OK, we'll start looking at all your data that we have been telling you we need for the last two years". Simply taking the data package a reviewing it....not approving the drug. With the rolling NDA, conditional approval, ADCOM, AA and denial all options after this package acceptance. Unless I am missing something or there is some unprecedented dynamic, why would they not be ready to start unpacking the package. KGR
Agreed. Their lottery ticket never seems to run out of amo, but I do believe, one day will make their last 2 years a waist of time. GLTA KGR
The newest indicated product for epileptic seizure's. This may be different, but I think NOT! Neurontin (Gabapentin) Was initially indicated for Epilepsy.....50 million Market. Now Gabapentin is used for Neuropathic pain....billions (Pfizer take over from Parke-Davis)...new indication and by far more prevalent. Think of Viagra, initial indication....Systolic/Diastolic Hypertension and CHF. Now Viagra is worth billions for erectile dysfunction. Just wait and see how the flood gates open if approved! KGR.
Grey, I have always appreciated and respected your posts. However, if there is one drug approved for DMD, than you will certainly see outside labeling use. I assure you, I have been there. If anyone thinks a diagnosed DMD patient with a specific Exon 51 diagnosis is commanding the only prescriptions, your sadly mistaken, especially if Drisa is delayed. Trust me, I have seen it. Maybe not like 10 to 20 years ago, but there will be an off label push....due to decades of demand. KGR
Fair enough, we will see. Remember, this is a rolling NDA with additional exons being studied. You may very well be right regarding reimbursement, but I guarantee you, there will be a push outside the domain of Exon 51. Respectfully, KGR
Look, I know I am going out on a limb somewhat, If Etep is approved with excellent safety and Efficacy profiles... they will treat far more than Exon 51's, I assure you. Tacrine (Cognex, the first available treatment for Alzheimer's) was approved for early onset Alzheimer's....many advanced staged Alzheimer's were treated. The same with Aricept. This is an unmet disease state, there will be a push and stretch on it's usage.
If ETEP gets approval, they will not be valued into the Exon 51 corner, pigeon holed...whatever. Once Physicians get their hands on an approved drug, they will aggressively treat DMD.....period.. If a child is diagnosed with DMD, they will not care what Exon genotype they present, they will be treated for what ever DMD that walks through their door, with the only Treatment available. Physicians will prescribe 100% off label (If you want to think of it that way). We are studying efficacy in other exon trials for further validation, but physicians will not wait two years to ascertain the trial outcomes. Especially, when safety will be clearly validated and with only one option available for an unmet disease state. Bottom line, do not value ETEP on EXON 51 alone...big miss!! KGR
Case and point. Lipitor (the highest selling overall drug in history) was developed by Parke-Davis, a relatively small company. Lipitor's effect on lowering lipids were slam dunk better than anything on the market. The initial launch was uncertain, until Pfizer partnered....then BOOM! Marketing muscle and timing are of paramount importance when launching a new drug. We give too much credit to Doctors. If they are so smart, why has the FDA (which are SUPPOSE to be prominent specialists Doctors) delayed the best DMD drug on the planet for 3 years. If the obvious cannot be sold to the FDA, why do you expect anything different from the busy ordinary clinician? ETEP will come out late and BRMN will capitalize on timing and over sell an inferior product.
I was not trying to specifically relate their need for new and innovated products to SRPT. However, with all of the patent expirations (especially Lipitor),if ETEP and the exon skipping domain is clinically and commercially viable, then the Macro's will be hunting down the up and coming Micro's. As others have stated on this thread, many Pharma's are short cutting the lengthy and expensive R&D (preclinical to approval, 5 plus years, risk of failure and very expensive with the P1 through P3 trials). Rather, by acquisitions of promising later stage drugs and platforms, the smaller company has already taken the risks and done the grunt work and funded the high risk phases of development.
SRPT seems to fit.
Now Pfizer’s management team is looking for products or a business to help make up for patent expirations of what once were blockbuster drugs. And a deal could be big or small.
“I don’t think we’re looking at limitations on size,” Read said in an interview. “With size sometimes comes complexity
Remember the old garage doors openers that were dependent on the coiled spring. If they go, serious harm to anyone nearby. The shorts are standing next to an imminent uncoiling night mare.
We were on the phone at the same time during this crisis. I told him what he posted and I did not like the fact the he gave names and locations for family confidentially purposes. If you continue to persecute my family and create animosity....you are responsible. you have already tormented us to the 10th degree. You make your choice as to how you would like to make my family suffer. I told Pearsby to hold off on his posts for at least a month....YOU..need to do the same!! She is dead...feed on it if it makes you feel better. However, it will not make me feel better....SHE IS DEAD #$%$ HOLE...Take a screen shot of this!
6 years on this board...minimum. More than 90% of investors....SHE IS DEAD....go for it!
I have been long for six years...May be. Lost tract. Check my history for the last 5 years...pro CTSO. I lost a close friend and family member and you are anextremely insensitive SOB.