AK....Next time you need to tell me a stock is going to double in about two months and I'd bought it regardless...! LOL.... Nice job on ESPR for sure....
ZSPH.... If both RLYP and ZSPH go according to Hoile and get approved, and the market is as large as the pundits think it could be...
I firmly believe both companies will be acquired... If simply makes too much sense. Large potential market and an unmet medical need. Only two approved players and drugs to address it in the world. Both one drug companies. 1-3 billion dollar per year in potential sales split between only two companies. Both pretty cash rich right now. If I have ever seen a buyout set up, this one could be it IMHO!! So obviously I want to own both and fairly large too.. You should too if you will let yourself see the forrest through the trees...
Just bought more ZSPH at $41.18 avg...Building a fairly large position now AK....
Yes...Every once and awhile the bio Gods descend upon us and remind us that we are certainly
not invincible, nor gurus, and just mere mortal men who should never equate pure luck with genius!
Very nice run from the low 31's in the recent biotech sell off. Gotten rid of all the resistance going back up
except we now need to close above $42... That ladies and gentlemen should be the promised land thereafter... The chart right now though is looking very good....
AK....We're getting wacked today in ZSPH?? Any reason that you could be aware of ?
AK....You saw what happened to AERI tonight I hope. Let's hope CLDN doesn't pull that...
I'm out but wishing you good luck on that one!!!!
I'm sorry cynicoptimist that you have lost so much money this week ($19.8 to $12 plus) but don't blame it on me, or Jason Napodano, or anyone else but your greedy self. This stock simply got way ahead of itself for where it is today, and a lot of little folks hoping to make a killing piled on, and there you have it...Not saying it may not have a very bright future, but it is way too early to tell. Most folks here are totally clueless on the process that lies ahead to get approval. Just do a couple of patients....throw on some stem cells....and the
device gets approved and everyone becomes multi millionaires! Good luck to all of you! Had enough fun for tonight. May well be back after they have done at least five patients and gotten verifiable positive results.
Would rather pay$25 for something that is real than $12 for pie in the sky, but obviously that sentiment is
in the vast minority on this Board tonight! LOL! Cheers to all longs and best of luck!!***
***think you folks may need it frankly...
Mike...When you mix a living organism like stem cells with a medical device you come under an entirely different review and process with the FDA than you do with purely a medical device. The use of stem cells under any way, shape or form to be introduced into the body of a human being, is directly regulated by
the FDA under the more stringent requirements of a "drug" rather than simply a medical device.
Jason Napondano, who is a well respected biotech analyst with Zack's, and who brought NVIV to many of our attention, commented on her disappointing "neurological assessment" on April 20th on Twitter...At that time he was expecting perhaps a PR by the company on the assessment....Don't be scared of technology...
embrace it...Get out of the rocking chair and get on with it man!
longnvivuntil50.... Read your post and your question to your friend "Mike". When you mix a medical device with stem cells you're in a whole new ballgame with the FDA. You go from a medical device approval time frame to a "drug" approval time frame...Lengthy and large clinical trials, and 4-6 years to approval, maybe even more if you run into any major issues. IMHO...
The "science" behind this medical device is not the issue. It's apparently safe...The question is does it work.
First of all pal...it wasn't a quotation. Did you see " " next to what I was paraphrasing?
Next...You're obviously not up to speed here.. The results of Patient 2's recent check-up were
reported all over Twitter a few days ago.. It was the primary reason the stock went down four days
ago off it's highs. Read up and get informed.
Hey, you copy Wikipedia really well....Nice job. Bet you did that using other people's homework in school too.
As an FYI...I was a founding shareholder in four medical device companies that went on the NASDAQ, two of which were bought out later, one by JNJ. The bottom line is the physician has the ultimate decision to use or not to use any given device, or drug, whether under an HDE or otherwise. My point was simply that NVIV has been given a free pass on up to five patients under an HDE. Thus far the device appears to be "safe' so that is a positive. With the first two is is doubtful that one could say it works to any degree or not. My only point was that for the next three (3) patients the device needs to be shown to actually produce results.
Patient 1 was in the category of maybe it did, maybe it didn't. Patient 2 seems to be in the category at this
time that it did not produce any meaningful results. But she inturn had a more severe spinal cord injury than
My earlier point was simply that might it not be wiser to invest in this company after trial results have shown at least one patient who's injuries responded to the scaffold with unequivocal positive results? And yes...I owned the stock pretty large at $1.40 and sold it just over $3 pre split.
HarvardmeatsyourlocaJC.... Almost as dumb as your call for $25 in the next four weeks...Is that the amount you need to save your mortgage? Good luck to you!!
To "Mike" the resident guru here....What part do you feel is "ridiculous". Do you not know the regs that are involved here? The company under a HDE gets a very limited number of chances to prove their drug or device works, is safe, and addresses an unmet medical or medical device need for a serious condition or disease. Even one major
problem can and will put the kabosh to an HDE. Didn't they tell you that when you
graduated from gas station attendant school? Let's compare degrees...work experience...
and knowledge in the areas I wrote of big man....
People here need to understand that a physician under a HDE just cannot willy nilly grab anyone who comes into a hospital in an emergency situation and implant an investigational device in their spine. Those types of procedures require the physician and the hospital to comply with specific FDA language, applications, approvals and regulations. If the physician abuses those regulations his license could be in jeopardy.
One of the criteria that the hospital and physician must represent is that the investigational device being used is likely to provide material benefit to the patient, and that a similar FDA approved device is not available elsewhere. While the second criteria might be applicable to the scaffold, what about the first?
When the initial scaffold was first implanted in a patient the first criteria was believed to be true.
But now there seems to be at least one physician with Patient #2 who said he observed no benefit
whatsoever as the paralysis is basically the same today as it was right after the device was implanted.
So it may well be more difficult to use the device in further patients if they get similar results to Patient 2.
As for Patient 1..Was the improvement perceived a result of using the scaffold or simply did the patient
sustain less severe spinal cord injuries than Patient 2? This could well explain why we haven't seen
any new implants of the device recently. The company can literally not afford more results like Patient
2 so maybe they are being very careful in handpicking the next potential patients....IMHO...
5 thumbs up for an article where the scaffold was implanted in a "rat" and the conclusion was that the "regeneration achieved was not sufficient for inducing functional recovery." And you feel this
2 patients equals 175 million in market value per patient?? Seems about right....
That, and I guess there hasn't been any other spinal cord injuries in the U.S. in 3 months and
certainly none in Sourthern California where I live (and where U.S.C. is allegedly another
approved center to use the scaffold)..... Glad to see that people nationwide are being alot
Testing "safety" idiot stick does not mean you do not expect some efficacy otherwise you wouldn't bother with a surgical procedure of this nature in a spinal cord injury for goodness sakes. To get this type of exemption you have to convince regulators that the risk of the procedure is worth the potential outcome
to the patient, not that you, the company, is just seeking some "safety" verfification. You generally use animals for that purpose.