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WOW... thanks hippo. I'm assuming this is what WH was referencing. Beautiful. Got some more reading to do tonight. I've also speculated Leonard is more involved than we think
There were bigger buys than that. Atleast one $100k buy went through. All around the same time on Thursday
Our chairmans last company sold for $2billion with much less potential.
It's not?...
"Yes Buffett did invest in pink sheet penny stocks when he was young, according to the book The Snowball. He loved investing in cheap stocks at discounted prices, which at the time were bargains. He made a vast fortune buying penny stocks and day trading. Buffett was investigated by the SEC in 1974-1976 for manipulating the price of a penny stock called Wesco. Him and Charlie Munger bought shares at a higher-than-necessary price. Buffett did this as he was buying the company and had made a promise to a shareholder that he would keep the price above a certain number. He sort of admits what he did was wrong, but it didn’t affect his reputation and one of his companies had to pay a $115,000 fine."
Mr. Murphy's last company was bought out in 1995 for close to $2bil
http://www.nytimes.com/1995/11/07/business/cordis-to-be-acquired-by-johnson-johnson.html
Imo his current company, US Stem Cell has much greater potential. Adjust for inflation. That is why you see these predictions. I'm just gonna ride my free shares from here, imo the potential is great but I won't put a price on it until we have some type of FDA news. Which could be very soon
No it's not lol
Convertible notes, toxic debt is gone. Read the 10k. Read the charts haha
Yep, and the longs here that do some serious DD sounded very excited last night.
Something very nice is brewing. Between the buyout offers mentioned in pacer docs and FDA news upcoming, this thing has the potential to POP. Those multimillion share buys on Thursday should sway anyone's doubts about this company.
They already found it.
Keeping it caged until the right moment. Who released the news first? Humacyte pr or the FDA? Hmmm
It's easy to figure out
Correct, and we have a whole lot of clinical data from the last 10 years, including our affialaites overseas. We are golden imo. I can wait til may to find out, but I doub't I will need to haha
The million dollar question here. All anyone KNOWS is that they submitted the application before the CEO's blog update a couple weeks ago. Many here, with good reason, speculate they applied end of January
I agree, Just
helping to correct snugs confusion about the process to commercialization
Expediting commercialization
"The implementation of the RAT designation process will enable manufacturers to begin to take advantage of the less burdensome review process enabled by the 21st Century Cures Act."
RAT Designation Process
Requests for RAT designation can be made concurrently or at any time after submission of an IND. FDA is required to respond within 60 days. If CBER’s Office of Tissues and Advanced Therapies (“OTAT”) determines that a RAT designation request is incomplete or that the drug development program does not meet the criteria for designation, it will inform the sponsor and include a written description of the rationale for its determination. FDA’s RAT website also provides that:
Sponsors should refer to FDA’s Expedited Programs Guidance for FDA’s interpretation of whether a disease or condition is “serious or life-threatening” and whether a drug is “intended to treat a serious disease or condition.”
Consistent with fast track and breakthrough therapy designations, FDA does not expect that sponsors submit primary data. Instead, FDA requests that sponsors describe the preliminary clinical evidence.
Sponsors should provide a brief description of any available therapies for the disease or condition, the study design, the population studied, and the endpoint(s) used, and a description of the study results and statistical analyses (e.g., subgroup analyses).
Requests for RAT designation should be submitted to OTAT.
The cover letter for a request should clearly specify that the submission contains a “REQUEST FOR REGENERATIVE ADVANCED THERAPY DESIGNATION” in bold, upper case letters.
It's all spelled out for you in the 21st century cures act and RAT designation explanation. Usrm can essentially use all of the data the they've been compiling over the last 10 years. The have studies going all over.... Mexico, Europe, Asia. Hungry hippo already did this DD. Just gotta actually read it
Benefits of RAT Designation
RAT designation affords the following benefits to sponsors:
Expedited development and review by FDA (i.e., the same actions as for breakthrough therapy designation);
Early interactions “to discuss any potential surrogate or intermediate endpoint to be used to support the accelerated approval of the product;” and
Eligibility for accelerated approval under current FDA preapproval standards but with new postapproval requirements.
Signaling for Expanded Use of Accelerated Approval
The new postapproval requirements are a key differentiating factor from the breakthrough therapy designation. Sponsors of RAT-designated products approved via the accelerated approval pathway have additional options to meet post-approval requirements beyond the standard, controlled clinical trial. Post-approval requirements can be met through:
Clinical evidence, clinical studies, patient registries, or other sources of real world evidence, such as electronic health records;
The collection of larger confirmatory data sets; or
Postapproval monitoring of all patients treated with such therapy prior to approval of the therapy.
The new designation, therefore, encourages FDA to further develop and utilize the Subpart H/accelerated approval pathway. For a comprehensive review of FDA’s use of accelerated approval, refer to our paper, here.
Notably, the January 2015 House version of 21st Century Cures at section 2041 addressed regenerative medicine from a different angle. It directed FDA to issue a guidance document on surrogate and intermediate endpoints for accelerated approval of regenerative medicine products. Although this original approach was less ambitious, it also highlighted the need for accelerated approval to bring to market products in the budding field of regenerative medicine.
Let's talk about this Cigna thing some more.. if this gets FDA designation soon, it will be reviewed by Cigna and very possibly covered. Covered by ANOTHER major insurance carrier. Think about that. $$$. Cigna, bcbs, who's next?
These are just a few reasons so many think it'll be approved:
Kristin Comella, our CSO was instrumental in lobbying in front of CONGRESS in support of these new FDA protocols towards these types of treatments (stem cells). She's a world renowned expert on this subject matter and leaders take her seriously.
The MARVEL trials have proven to be very effective and a vast improvement to the standard of care already in place. Hippo has posted plenty of DD on these trials. The FDA tends to support new treatmentsfor serious illnesses that show this type of improvement.
Our chairman of the board is very well known and respected in the medical sphere.
The current political climate is pushing for a more streamlined and less complicated approval process for innovative medicines. Trump wants to deregulate the FDA and his pick the head the FDA is very pro stem cell and he also wants to make the approval process easier and less costly.
Monitoring. Or hinting. They know they're golden
Tomas was a very busy man this week. I bet. Eom is gonna be funnnn, well for those of us who haven't sold atleast
Hint hint**
Nice find! The team has been very busy of late.
Hmm wonder what Mr. Tomas has been up to haha guess we'll find out soon
Lol nice close shook the noobs who didn't know what they owned
They have no idea haha
Haha AH news is gonna be that much sweeter with all these weak hands out
Flashing millys just like yesterday right before ph
That's what you call a thin ask
Big trades. All started with that huge 1mil slap haha
Last Friday A/H gave us a nice form 4. This friday...?
Gonna be interesting based on the size of those bids yesterday. Definitely not ihub money
Haha watch this go dark immediately
Exactly. Add in the recent buyout offers mentioned in pacer docs and FDA news coming any day/week, anything could be possible. Or just pure technicals taking her up. We shall see
It was amazing. Especially after watching them flash 1mil on the ask a few times. Then bam someone slapped that ask hard.
Other healthcare stocks didn't jump like this. In fact many went down even after the news of delay. Imo the news was not the cause.
On the other hand... trumps admin is promising staggering deregulation to the FDA, making the process for biotechs in the stem cell business much easier and less costly. On top of that, trumps pick to head the FDA has spoken extensively on his pro stem cell stance. Take everything you read here with a grain of salt
Big buy after big buy after big buy
Someone's gotta know something
lol that slap was great. A little excitement on a slow workday
Yup. They'll get caught eventually lol
Lol tic toc