GN.22 Research Group Signing Off
The decision to publicly assist the Human Trials Research team was not taken lightly, and everyone within our team was aware of the risks we would be undertaking by being the public face of a project that was no longer under our control.
Unfortunately all of our main concerns materialized, and the amount of public scrutiny that we have had to endure made it very clear, at least to me, why Research Groups tend to be enclosed environments. Note that this was not just limited to the comments we received within our own community, as many of them were encouraging, positive, or constructive criticism.
As we entered into the Human Trials, at least 50% of the comments we were filtering out due to their offensive or insulting nature, all aimed at our staff and ultimately putting our professional integrity in question.
The comments were not limited to our site; we have received numerous emails from colleagues pointing out multiple instances where our work was put in question. Do note that criticism has not been directed at our published data or methodologies being carried out; they all seemed to follow a very similar pattern, consisting in uncontrolled personal attacks with the sole objective to denigrate our image and professional careers.
These comments and accusations can be found across the most prominent Hair Loss thematic communities across the web, and most range from outrageous to defamatory. Today we inclusively received yet another series of comments contesting my personal academic credentials, claiming that I was inept to conduct a research due to a scarcity in scientific publications. Now as scientists, we have a certain degree of tolerance for speculation and scrutiny, this is however limited to the object of study and the process being conducted.
While I strongly agree that free speech is a fundamental Human right, I believe that it does not give anyone the right to publicly publish unsubstantiated allegations that could potentially jeopardize someone’s career without backing these claims with factual evidence. As a result, we are seeking legal advice in order to address this issue and to mitigate against published statements that have had, and continue to have, a negative impact on our staff’s professional integrity. (Including my own)
Unfortunately we have surpassed our tolerance threshold, and this has lead to a collective decision to stop updating this blog, effective immediately. We are currently holding talks in order to assess the potential future of the community, as technically it never belonged to us. Hopefully there will be an update regarding this in the near future.
Rest assured we are not abandoning Norma, it’s far more important than any of us individually, and it certainly would not make any sense at this point to retract from the outstanding progress that has been made.
To everyone who has supported us, we plan to provide an email address that you can use to inquiry about project progress. There are a couple of available options we are considering, from setting up regular project status through a newsletter, to opening an invite only Discussion Group. Whatever the solution might become, we do not intend to keep you out of the loop. Sarah will make a final post addressing this, but the plan is to open this to users who are already registered in our database who have provided valuable contributions to the community.
I would like to thank everyone who has accompanied us through this amazing journey and nourished our team though words of encouragement and constructive engagement. At the end of a long night locked in a lab/office, you were the reason why the long hours paid off.
Thank you.
Jason Wats MD
Norma Progress Report – Delay
Not the best of news unfortunately, at the beginning of this week the first administration of the treatment was scheduled to take place, but we have been alerted to the fact that not all required authorizations are currently in place for the team to progress.
While this is not uncommon, and despite this being a privately supported clinical trial, the team does need to have everything in place to carry this through.
Will keep you updated as soon as we have more information on the matter.
Norma – Human Trials now in progress
I can´t say how pleased I am to announce that Human Trials are now in progress. It is a culmination of months of research and hard work, and to see all of this effort finally pay off is an amazing sight for all of us.
Do note that the organization that is taking up this endeavor would never undertake this if they did not recognize the potential of this treatment and its impact on peoples lives.
I know most of you are anticipating the results of the trials, but we are still in the beginning of the process, so do not expect to hear about results immediately.
Remember that Human Trials have to follow certain guidelines and principles that do not leave any room for conjectures, so unlike our research project where we were able to “open our doors” and share information in an informal way, this phase of the project is obviously different.
We really pushed towards getting a schedule elaborated so that you could know what to expect in terms of delivery and reporting, but unfortunately it was not possible, and understandably so as the team that is leading this charge did not feel comfortable in setting expectations.
So when will you have a status on how things are going? When a report has been produced that has been signed off by the team as a “deliverable” document, we will share it with you. As to when this will take place, it’s hard to predict and I would just be creating unnecessary noise by talking about dates, but I feel it is safe to assume that it is likely to happen within this calendar year.
In the meantime, we will try to update you on the project at a very high-level with any information that we feel will not jeopardize the amazing work that is taking place.
We truly appreciate this community’s continuous support, and we understand how anxious you all are to finally know if this is in fact the treatment that we all hope that it is. In a way, even though we have been directly involved in the project, we share the same desire, and we are all in the same boat.
We need to go back to posting regular updates on our blog, and I am referring to non-Norma related topics as well, so we will most definitely get back on track this year.
Norma Status – Clinical Trials – Green Lighted
We do realize it’s been far too long since our last update, but it’s been quite impossible to sit down and provide a retrospect on how things are progressing, and what has been happening during the last weeks.
We have been more involved in the Clinical Trials than we expected, and admittedl liked to be. The first phase of the trials have been extremely “paper-work” intensive, it has proven to be more of a logistic operation rather than a scientific Research project.
Let me thank everyone from this community for applying for the trials, out of the 120 candidates, we have selected 16 that applied through this community, everyone that has made it to the program has already been contacted. Rest assured that in case we extend the trials to areas outside of Delaware, we will let you know.
All of the legalities and authorizations are nearly in place, and things will finally kick off before the week is over. We are still not sure how we will be reporting on the progress, but hopefully the team that is leading the tests will be granted access to this blog and will be able to post regularly. Regardless of how things will move, we will keep you updated.
I have asked Jason for more help to keep the community flowing, and we truly appreciate your continuous support!
Norma Project Status – Clinical Trials
As most of you know by now, we are in the preparatory stages of assisting an external team in the Human Trials for project Norma. Unfortunately we cannot release specific dates art the moment but I can tell you that the trials are expected to start sooner than previously stated.
Would also take this opportunity to inform that the research team is looking for candidates that reside in the State of Delaware. We will be posting more information regarding the clinical program as soon as we can.
Project Norma- Human Trials
I am pleased to announce that we have reached an agreement with a private organization that has agreed to advance with the Human trials for project Norma. Unfortunately we cannot get into too much detail at this moment, but we will be releasing more info during the next couple of weeks.
As many of you have requested, we will be posting information regarding the process itself and how to be a part of it, but there is still quite a bit ground to be conquered in the weeks ahead, particularly regarding HSS permits.
We are expecting a mid/2012 time-frame, but it’s still premature to talk about specific dates.
Would also like to state that our research group will have a passive role in the testing process, we will not be part of the team that will be conducting the tests.
Spectral F7
We gave been receiving an enormous amount of questions regarding a product called Spectral F7 that allegedly is based on Astressin-B. We would just like to state that during project Norma, Astressin-B was not tested topically, which means that we cannot prove or disprove in any way the efficiency of this treatment.
I would also like to point out that we have not received nor have we requested samples of the product for testing.
While we might have expressed our doubts regarding the efficiency of a topical treatment based on the compound, it would be premature and unprofessional to openly state that it doesn’t work.
Human Trials – Norma
As Jason pointed out in the Preliminary Report, we are currently in talks with a privately funded organization that is interested in conducting the Human Trials for project Norma. While there is still a lot of planning and details to be, we are confident that we have found a suitable partner in this endeavor.
While our research group will provide technical support, we will not be involved in the logistics of the trails.
During the upcoming month we will be posting a link with the details to get our community involved in the trials. Now, let me just demystify one thing; entering Human trials with the mindset that you are going to have contact with the compound is not a good idea. Human trials are experiments, they are not treatments. Remember, a great percentage of the dosages are placebo and/or very residual doses of the compound.
Norma Astressin-B – Preliminary Report
Introduction
The findings below are still a “work in progress”, and while they do provide a very good indication of what the final report will look like, slight variations and alterations are to be expected, so please do take this into account when comparing preliminary data with the final report. The preliminary report does not explain the basic concept behind the study; it is a mare enunciation of data. To understand the purpose of “Norma” please consult previous reports on the project.
Unfortunately due to unforeseen circumstances we are currently unable to process data from Parcel C. Hopefully we will be able to resolve the pending problem in the upcoming days.
Dosage and administration information has been intentionally suppressed from the report. Materials will be detailed in the final report.
Methods
Each subject was placed in separate cages in order to avoid over population and social interactions that would affect the results. Cages were occasionally placed in close proximity in order to maintain minimum social interaction ratios. The compound was administered intravenously during specific intervals. Subject CRF levels were also manipulated in order to replicate specific conditions.
Data
Parcel A.A: 99% of the subjects are showing full regrowth, while 1% a significant results. Mild Gastrointestinal side effects noted, most notably diarrhea, and moderate salivation. Very mild hypersomnia was also registered.
Parcel A.B: 91% full of the subjects are showing full regrowth while are showing 8% significant regrowth and 1% of the subjects are showing moderate progress. Very mild gastrointestinal side effects noted, most notably diarrhea.
Parcel A.C: 87% full of the subjects are showing full regrowth while are showing 10% significant regrowth and 4% of the subjects are showing moderate progress. No side effects noted.
Relevant Annotations: The dosage of the compound in Parcel B is similar to the one in Parcel A.B, which we have determined as our mid-level dosage. Note that while none of the sub-parcels have standard CRF levels; every parcel has a control group with a neutral CRF expression. B.A being the highest expressing group, B.C is the lowest; even the lowest expressing CRF sub-group has significantly higher CRF levels than the neutral CG.
Parcel B.A: 19% of the subjects have showed full regrowth, 28% of the subjects are showing significant regrowth, 32% are showing moderate results, 18% minor progression, and 3% showed no signs of improvement. Moderate Gastrointestinal side effects noted, most notably diarrhea, accompanied by mild salivation and minor weight loss.
Parcel B.B: 44% full of the subjects have showed full regrowth, 34% are showing significant regrowth, 12% are showing moderate regrowth, 10% minor progression. Minor Gastrointestinal side effects noted, most notably diarrhea, accompanied by mild salivation and minor weight loss.
Parcel B.C: 52% full of the subjects have showed full regrowth, 36% of the subjects are showing significant regrowth, 12% are showing moderate regrowth. No side effects noted.
Preliminary conclusions
• It appears that lower dosages of the compound are not as effective
• Extreme dosages of the compound are not increasing its efficiency, but do seem to aggravate side effects. (data not present in any of the above parcels)
• The efficiency of the compound decreased as the CRF levels increased,
• Noted side effects ranging from minor to moderate: Gastrointestinal occurrences, most notably diarrhea, leading to dehydration and weight loss. Loss of muscular mass, salivation, and hypersomnia,
• Compensating extreme levels of CRF expression with extreme dosages of the compound aggravates the side effects and does not improve the efficiency of the compound,
• Subjects without extreme CRF levels responded at optimal efficiency levels having been administered moderate to high dosages of the compound,
• Significant interruptions of the administration of the compound resulted in further hair loss, (support data not present in this report)
• Intermittent administration of the compound resulted in a moderate decrease in its efficiency.
Considerations:
The next update on project Norma will be the actual final report. We estimate that the document will be done by the 5th of November, but I believe it is reasonable to state that the data will not look too different from the preliminary report. As stated before, the documentation will be made publicly available, and we will be more than open to provide additional information to privately funded research groups.
We have also been in contact with an organization that is interesting in proceeding with the Human Trials. There will be a post on this subject as the week progresses.
Norma – Status update
Hello everyone, we do apologize for the lack of updates recently, but we have been a bit short on staff in the last couple of weeks.
As promised, the preliminary report will be posted in 48 hours, we really appreciate your patience. Unfortunately the third Thyroid series installment is a bit late, hopefully I will get around to post it as soon as things get normalized.
Recent Posts
- GN.22 Research Group Signing Off
- Norma Progress Report - Delay
- Norma - Human Trials now in progress
- Norma Status – Clinical Trials - Green Lighted
- Norma Project Status - Clinical Trials
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