Isn't it amazing how vermin (like these shorts) come out from under their rocks to try and get me to sell---why are you wasting your time--Long and Strong PAL
The components of this polymer have been used for years (and FDA approved long ago) and as noted previously dissolve in H20 and C02 in the body so there is no "foreign body" left behind--I also have never doubted that this "safety" trial would be successful--I don't think there will be any "landmines" toward getting to the pivotal trial likely early next year
"Bless Al Mann and to hell with anyone who wants to see this fail"
Public enemy #1 is Adam Feurenstein and the clowns from "The Street"-he has continued to bash MNKD and Afrezza from Day 1 (wouldn't get past AdCom/wouldn't be approved by the FDA/MNKD wouldn't find a partner to market it/and now his most recent post (January 5)-Sanofi will "dump" Afrezza after it commercially flops)-
I agree--the one thing that In Vivo values more than anything else is the relationship they have developed with the FDA-they won't reveal anything (without FDA approval) that would undermine this---and its clear why--that relationship has resulted in the scaffold trial parameters being less restrictive/14 additional sites added to the trial from the original 6/lifting of the timing for adding additional patients to a more "accelerated" rate---I would bet this relationship is going to go a very long way towards the ultimate approval of the start of the neural stem cell + scaffold trial
Sentiment: Strong Buy
very disgusting article in Seeking Alpha--no basis in facts/doesn't take into account extensive pipeline-upcoming catalysts etc. etc.-claims company isn't worth more than $0.70--I'm glad he wrote this piece I was running out of toilet paper!!
Again I'm not proposing these timelines---In Vivo is--contact their investor relations if you think their "clueless" but what they have outlined
Read the In Vivo investor presentation--all I'm stating is what they have outlined--why am I "clueless"--I'm not pulling these timelines "out of a hat" (I've been invested in this company since 2011)--I would love this scaffold to become a standard for acute spinal cord treatment ASAP (as well as getting the scaffold + neural stem cell trial to get started as well)-BUT the company is clearly being cautious as to the "speed" to which things will progress-"unbridled enthusiasm" isn't going to get this scaffold to market any faster
I'm very happy to be overwhelmed with "thumbs down"--but I'm just noting the sequence/time line of events as outlined on the In Vivo Website investor presentation---I would love to be hammered for my comment by events that may follow in 2015-but being "overly enthusiastic" may only lead to disappointment
According to the accelerated clinical trial development plan (outlined by In Vivo in their presentation to investors July 2014)-the pilot clinical trial (N: 5 patients) won't be done until the end of 2015--the pivotal study (50-100 patients) won't start until 2016 (that is if the FDA agrees) and won't be completed until 2018--HDE submission would then take place in 2019--as such this stock is something that will take a very long time to reach its full potential and there are still many "roadmines" along the way that makes this a risky investment--I hope the trial is "wildly successful" and neurosurgeons are clamoring to use the scaffold ASAP but otherwise I wouldn't be looking at any miraculous rise in pps for a long time
The bowels/urinary bladder is controlled by the sacral nerves, which are below the lumbar nerves. If the spinal cord was severed at L1, that individual would lose control over their bowels/bladder, since the sacral nerves would be affected, too. So complete T11 severing would cause loss of bladder/bowel function
I greatly respect your opinions and value your comments
--would really like to know do you think that the fact that the FDA has essentially lifted most of the restrictions on this "safety" study--timeline for entry/broadening the inclusion criteria/opening the trial to 20 sites from the original 6 means that something far beyond "safety" was achieved in this first patient? Could the results have been so exempliary that the FDA wants this study done ASAP so that a scaffold + neural stem cell study can get underway?? I really believe that In Vivo has very carefully been cultivating a working relationship with the FDA and is being very cautious about saying much about the results-but the recent rise in the pps seems to suggest something more than just the lifting of the timing restrictions
"doesn't consider competition from Stem Cell developers (who may not need to use a device in tandem with their therapies"
my understanding is that they have been "plunking" stem cells into sites of ASC injury with little to no benefit (isn't this going on in China---I've read a lot about medical tourism to have this done)--I was of the understanding that the microenvironment at the site of injury is simply too "hostile" to allow these stem cells to flourish--hence the advantage of the scaffold as an "anchor"---that's why I was wondering about what CUR is doing---isn't it the same thing as just putting stem cells into the injury site as has been done unsuccessfully before??
this "telecomdomainpro" maybe immansthrope under another name--he'll be proven wrong just like his negative troll counterpart
Thanks for this post--this moronic troll has blocked me from responding to his dripple-being the low life that he is--glad I have someone else to stand up to him
The fact that the FDA is now allowing the study to be expediated tells me that the first patient surpassed the "safety" end point they were aiming for---I admire Mr. Perrin's leadership in all of this as I have said before he is cultivating a very good working relationship with the FDA and not giving into needless hype/cheerleading---this slow steady approach is what's going to win this race
Sentiment: Strong Buy
keep it up "Shortie"--have continued to add to my position on dips--your contribution to this is greatly appreciated!!!