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Agreed. I've just seen prices stay "irrational" on the OTC for a long long time. Moving up to a major exchange will be nice.
After the drop yesterday to 3.30 and subsequent rebound on no news, then this PR today... You can not tell me that some fraudulent pps manipulation wasn't taking place allowing some big boys to take positions or MM covering shorts or whatever.
Look I'm happy with the news and I'm way long on this. But I can't wait until we uplist. Once that happens I'd feel better about committing more funds.
Hopefully we have some more PRs up our sleeve post uplist to keep momentum going.
Anyone else's opinion on this is welcome too.
We'll almost anyone. Lol
Thanks
Great post. Thanks for taking the time Maz.
Do you believe potential success in China is independent of Sequestox? Or do you feel Sequestox FDA approval is the lynchpin to a China strategy as you laid it out?
I think revenues from China distribution will ultimately play an outsized roll in the future of ELTP regardless of what happens with Sequestox. But when!
Thanks again
$ELTP
Thanks for sharing MDizzle
Can you tell me who is dumping? I'll take your word for it. But maybe a link for the others would help. Thanks.
If this runs to $1.50 I'll get you whatever diploma you want. Lol
GLTU and thanks for all the insight.
Lol. Gotcha. I'll keep an eye out.
Can you share with me "the pump" part please? Was there an SA article I missed or something?
Good call. Could not of nailed it better. Hopefully you picked up some shares today.
GLTU
Big move to the downside huh?
What would you say the percentage is of people making a living as a professional card player?
Plenty of non pro card players contributing to the success of the casino.
Not everyone in the market is trying to make a living of their trades. So plenty of non day traders contributing to the "industry" as well.
Which I'm not quite sure what you mean. Online brokerages?
Point taken. Sarcasm and all. ELTP has been a learning opportunity in many ways.
"most concur questions submitted are being answered in more orderly fashion."
I would agree 100% here. He reads our questions right off the page and hits them all from my perspective. Sure we miss out on a follow up. But I don't need to hear someone blow smoke up Nasrat's as for 5 minutes before they get to the point.
I think Nasrat got annoyed with that just as much as others listening to the call. And this way we make sure quality questions are in front of him to address without redundancy.
When he stops answering the SPECIFIC questions submitted from shareholders, or dodges important ones, then I'll be worried.
Until then, I like Nasrat's matter-of-fact disposition.
Thanks for sharing. Definitely reason to be optimistic.
Please sticky this post.
Fair points. Thanks for sharing.
That they do. Rated as a strong buy with PPS target of $13/share.
I expected more than 10% because of the significance of the 5th patient conversion. This meets the goal of 25% conversion rate needed per the OPC to consider this study successful. Even if all subsequent patients don't see any improvement.
This alone suggests that eventual approval is highly likely if not a forgone conclusion. Sure there is still a road to travel with obstacles before commercialization. But this team has proven able to work with the FDA and continue to progress the trial forward. No reason to suggest otherwise now.
I would agree that our first trip into the mid teens was based around hype. We didn't even know what the OPC would be at that point. But conversions in 5 out of 8 evaluable patients already meeting our endpoint isn't hype, IMO it's confirmation. And should support a move up to the $9-10 range. Again IMO.
"The FDA has recommended that InVivo include a control arm in the study as part of a Study Design Consideration. We are in discussions with the FDA on this recommendation, and we continue to believe that our current study design is sufficient to demonstrate safety and probable benefit in support of a HDE application for marketing approval. "
Doesn't sound like a "requirement" to me. However I feel like uncertainty around this issue is what's stopping this from trading in the high teens. May get there regardless over the next couple weeks with the news today. However I would of expected more than a 10% jump out the gate.
Also notably from the 10q I believe the modular shell submission displays the savy of management. That plus the lean cash burn as mentioned by in a previous post gives me confidence that they can execute there business plan and is only a matter of patience.
From 10Q:
"In late February 2016, the FDA accepted our proposed HDE modular shell submission and review process for the Neuro-Spinal Scaffold . The HDE modular shell is comprised of three modules, a preclinical studies module, a manufacturing module, and a clinical data module. As part of its review process, the FDA reviews modules, which are individual sections of the HDE submission, on a rolling basis. Following the submission of each module, the FDA reviews and provides feedback, typically within 90 days, allowing the applicant to receive feedback and potentially resolve any deficiencies during the review process. Upon receipt of the final module, which constitutes the complete HDE submission, the FDA will make a filing decision which may trigger the review clock for an approval decision."
With all that said the expectation of management is pushed back a bit from previous completion estimates. I think. But this is all we need to know right now.
"We are targeting completion of the study, which includes completion of enrollment, follow-up, and submission of the HDE application, in 2017."
In my opinion this is the reason for the delay in enrollment...
From the 10q:
"During the interactions regarding the approval of the expansion of The INSPIRE study to enroll up to 30 patients, the FDA recommended that we include a control arm in the study as part of a study design consideration. At the present time, we are in discussions with the FDA regarding this recommendation."
I believe they are just being cautious and making sure they iron out exactly what the FDA will need in order for approval.
Amen to that. Cheers.
InVivo Therapeutics Announces Update on the INSPIRE Study and FDA Approval of Expansion of the Study to 20 Evaluable Patients
Source: Business Wire
InVivo Therapeutics Holdings Corp. (NVIV) today provided an update on the INSPIRE study of the Neuro-Spinal Scaffold™.
Patient Enrollments
InVivo announced that the 9th and 10th patients have been implanted with the Neuro-Spinal Scaffold in the INSPIRE study. The 9th patient was implanted at Vidant Medical Center, a Level 1 trauma center located in Greenville, North Carolina. The implantation was performed by Vidant Medical Group neurosurgeons Stuart Lee, M.D., the Principal Investigator at the site, and Hilal Kanaan, M.D., approximately 40 hours after the injury occurred. Dr. Lee said, “The implantation procedure went smoothly and the patient is doing well. We are excited to be a part of the INSPIRE study and look forward to following the patient’s progress.”
The 10th patient was implanted approximately 18 hours after the injury by Domagoj Coric, M.D., of Carolina Neurosurgery and Spine Associates, Chief of Neurosurgery at the Carolinas Medical Center and a member of the INSPIRE Study Steering Committee. Dr. Coric and Dr. William Bockenek, Chief Medical Officer at Carolinas Rehabilitation, are Co-principal Investigators at this site. Regrettably, the 10th patient died from a stroke several days after the implantation procedure. The cause of death was deemed by Dr. Coric and the Chairman of the DSMB to be unrelated to the Neuro-Spinal Scaffold or the implantation procedure.
Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “We express our condolences to the family of the patient who passed away. Each loss of an individual with a spinal cord injury strengthens our resolve to develop and bring to market new treatments that will improve the lives of patients with these devastating injuries.”
Expansion of INSPIRE Study
As previously communicated, the INSPIRE study was approved originally to enroll 12 patients pending review of six-month safety data from the first five patients implanted with the Neuro-Spinal Scaffold. In addition to the 10 implanted patients, two patients were screen failures, which means that the patients consented to participate in the study but failed to meet all of the inclusion and exclusion criteria of the study. Although these two screen failure patients were not implanted with the Neuro-Spinal Scaffold, they were technically enrolled into the INSPIRE study. Therefore, the study had enrolled 12 patients by the end of May (when the 10th patient was implanted by Dr. Coric) and the enrollment of additional patients required action from the FDA.
After reviewing the six-month safety data, the FDA requested minor modifications to the INSPIRE study protocol and informed consent documents. These modifications are being incorporated, and the FDA has approved the enrollment of additional patients to allow for 20 evaluable patients (with six months of follow up data) in the INSPIRE study. Because of the frequent interactions with the FDA over the last several weeks regarding relatively minor modifications, InVivo chose to postpone updates on the INSPIRE study until there was clarity regarding the path forward. “We are pleased that the FDA has approved expansion of the INSPIRE study that clears the way for enrolling all 20 evaluable patients,” Mr. Perrin said. “While the pause in enrollment for the last several weeks was unfortunate, this approval is an important step toward our goal of approaching full enrollment of the INSPIRE study by the end of the year.”
During the interactions regarding the expansion of the INSPIRE study, the FDA also recommended that InVivo include a control arm in the study as part of a Study Design Consideration. Mr. Perrin said, “As is typical of the regulatory process, we have addressed a number of Study Design Considerations regarding the INSPIRE study and its pilot precursor study over the last two years. We have begun a constructive discussion with the FDA regarding this Study Design Consideration, and we will provide an update if substantial changes are made to the study protocol. We continue to believe that our current study design is sufficient to demonstrate safety and probable benefit in support of a Humanitarian Device Exemption (HDE) application for marketing approval. Given the encouraging results that we have observed to date, we look forward to working with the FDA to complete the INSPIRE study as efficiently as possible.”
View source version on businesswire.com: http://www.businesswire.com/news/home/20160712005620/en/
InVivo Therapeutics
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com
Thanks for this post. Connecting the dots with ELTP has been pretty easy over the years. But a few people on this board articulate it so eloquently. The underlining strategy, executive mindset on both sides of any possible acquisition, and then of course the overall potential. Thank you guys for that.
Even if it is all speculation currently, doesn't make it any less exciting! Time will tell. And very soon now.
GLTA
I saw it too. It is in the news feed of my Etrade account. Looks like Aquire Media is the source.. I don't have a link to provide.
There are plenty of developmental biotech companies that trade that hi without earnings. I'm sure you know that already. I'm also sure you know these types of companies do not trade on earnings but rather on potential and upcoming catalysts.
And we have those in spades.
Nicely put.
Perspective is everything.
GLTA
PuraCap controlling 68% of the narcotic market in China was news to me and was my biggest take away from the call. During the call I was hoping someone would ask where we stand as far as regulatory approval in China. Process, timeline etc.
No chance they are not all over SequestOx and will give Epic all the muscle they need to market it effectively here in the US.
Probably trying to renegotiate terms as Epic gave NH a layup of a deal as a parting gift IMO.
Is there any possibility that PuraCap could delay sales and marketing roll out as leverage in negotiations? N2K or anyone else's thoughts welcome.
Thanks good luck.
I empathize with the second generation longs. Those of us who opened a position post 97 run. Who accumulated in the 20s and may or may not be green right now.
The OG longs who were in at .06 already have their ROI. So this is win win jumping off point for the next area of growth for them. .30, .50? Doesn't matter. For me I was looking for a base closer to .80-$1. Then see where approval and the rest takes us from there.
So this 20% set back stings a bit.
Have to remind myself that this is just a PPS setback and in fact the CC was actually the best ELTP call I've heard to-date. NH has the big picture in focus. Even if it is posturing for a buyout.
If you doubled down at $5 you would be up 35% right now. Always easy in hindsight. We'll blow past $15 sooner or later. After the phase 3 initiation I would bet.
Good luck.
I like ATM financings. Just another tool in the bag. IMO sounds more like they're going to line up 2 or 3 PRs and take advantage of a potential price spike and additional volume.
Who knows when or for what. But Kim aways says to raise money when you don't need it.
Is there a reason for the end of next week time frame? They would be 3 months after patient 7s enrollment. The endpoint is AIS scale improvement within 6 months. And we've seen with a previous patient that conversion breakthroughs can take place in the later stages of this 6 month time period.
Regardless I agree we desperately need news on some front in the coming days/weeks.
Sounds like a good plan. In my opinion we'll stay range bound until one of the news events you mentioned happen. Personally I'd rather wait to see the beginnings of an uptrend establish itself with a few higher lows before I add. Even if it means I leave a few percentage points on the table. I'm staying long from here. So a move to $20 whether I grabbed some $5.50s or $6.50s isn't going to matter much to me. It's more about having my money stuck in a stagnant stock that bothers me.
It looks like it wants to begin a slow move up by maintaining $6 as it has. The opening of a new site or two or enrollment of a new patient would certainly help build momentum. But without news we likely drift lower.
However I will say another conversion and this thing explodes as that would meet our endpoint. Then speculation would begin on completing this trial postmarket.
Gltu.
Solid post.
I used $6 and $5.50 as potential bottoms because these two levels have acted as support in recent weeks and levels of supports have a tendency to do so again when tested.
Also note that those levels in my post were posed as a question, inviting someone with a "superior mind" to chyme in with their thoughts on a bottom or interpretation of the chart.
Both you and CI have made great points that I was unaware of and now will consider. And I thank you two for that. After all, that is what these boards are all about. However lets save the condissention next time.
Yeh that is a huge shelf no doubt about it. But we all know this doesn't mean these shares will all get issued tomorrow. Likely take years if ever for them to even get close to issuing half those shares. IMO it only increases there flexibility when negotiating partnerships, persuading high quality institutional investors and ultimately provides options to execute on their overall business plan.
They have money to take the NSS through approval. So dilution is not on the immediate horizon unless it is to expand other trials. Which would be a good thing. It would be foolish to wait until we are generating revenue with the NSS to take the next step and hope that no one beats is to the punch.
Beside this isn't exactly breaking news. It was voted on and approved the other week. So the PPS dip this morning is an over/delayed reaction.
Once a bottom is formed, and this headline is behind us, we start a slow but steady move upwards with potentially a ton of catalysts directly in front of us. This may even be the event some were waiting out.
I'd be interested to hear from some TA experts on this move. With $6 being some quality support, this looks more like a buying opportunity than anything else. If $6 breaks $5.50 next?
Again all in my opinion. Good luck everyone.
Exactly. My first purchase was 10k shares at .53. After more than two years of accumulation I now hold well into the 6 figures at an average price of .27.
Buying the dips after risk has been systematically reduced step by step by management. Most recently added a few weeks back at ~.31. All the noise around this stock has done nothing but allow me to load up at bargain prices.
And I know there are many investors just like me who have done the same.
Frustrating at times no doubt. But keeping an eye on the prize. Helps me sleep well at night. (Commercialization ----> Buyout)
Good luck and thank you ALL for your contributions to this board whether it is inline with my views or not.
I agree with you. Just nice to hear that a separate committee concurred with the principle investigator.
Delays in biotech are par for the course. The rate at which people get enrolled is what it is. Late 2017 has always been in my head as far as commercialization. And that interview doesn't change my view in any way.