GluStitch, Inc.
Tuesday, May 30, 2014
To Whom It May Concern:
The following is by way of offering a letter of reference for Care Research LLC. And Colorado Histo-Prep.
Our company enlisted the support of Mr. Bawa and his companies and support staff to conduct an animal study for a project we were working on in preparation for submitting a 510K to the FDA. All employees and ownership personnel were excellent in the
performance of their duties, and went well beyond our expectations to ensure the work was performed at the highest level.
The facilities are very well equipped, and the professionalism of the veterinarian as well as other employees directly involved in the actual process was impressive. Dr. Bawa went well out of his way to secure the correct animals for the study, and help with creating and modifying the protocol to ensure the process was as expected by the FDA, and the results were reported in an understandable and scientific manner.
Our company submitted the study to the FDA, and the FDA came back to us asking for additional detailed information. The FDA requested detailed semi-quantitative histopathology (with H&E and Masson’s Trichrome) and accompanying photographs which was not part of the original study requirements. This additional work was conducted at Colorado Histo-Prep and submitted to the FDA. They accepted the results without question.
In short, I take great pleasure in recommending the above mentioned companies to conduct any research and/or testing you feel necessary to help complete whatever project you may undertake.
Yours truly,
Don Blacklock, President
Mercia Pharma, Inc.
20 May 2014
Dear Rajan,
I would like to express our sincere thanks and appreciation for the contributions that Colorado Histo-Prep made in helping Mercia move our projects forward. Your team’s diligence, expertise
and cooperation have greatly facilitated the toxicology testing of our vaccines, and were particularly instrumental in helping us formulate a complete and timely response to the FDA concerning the clinical hold placed on MER4101, our MAS-1 adjuvanted influenza vaccine, currently in development under IND 15103.
The complete response we were able to file with the FDA has culminated in the lifting of the clinical hold for our prophylactic adjuvanted influenza vaccine, MER4101, allowing us to
proceed in healthy volunteers and ambulatory elderly subjects. As a result we have been able to resume our efforts in accordance with our program plans.
We look forward to continuing our ongoing relationship with Colorado Histo-Prep. We appreciate the ongoing high quality services you are providing for the pharmacology-toxicology testing of our vaccines and supporting documentation, including assisting us with our most recent efforts to prepare and file an IND for our therapeutic vaccine, MER3101, to prevent and treat autoimmune type 1 diabetes in patients with early stage disease.
Best regards,
Dr. Peter Blackburn
President
Mercia Pharma, Inc.
New York, NY
Colorado Division of Wildlife
November 7, 2001
To Whom It May Concern:
In the past year we have used the histological services of Colorado Histo-Prep, located in Fort Collins, Colorado, to conduct the complete the processing of several large and difficult batches of trout skeletal tissues. This work included trimming; decalcification, embedding, microtoming and staining with H&E. In addition the company also performed special stains such as Giemsa for a number of these studies.
We found the services of Colorado Histo-Prep to be of excellent quality as well as very timely. The staff at CHP is very receptive, accommodating and adaptable to our special requests. Moreover, they have been proactive in identifying areas for improvement both in their own processing and in the field collection and treatment of samples. This has enhanced our program by enabling better preparation of field samples and greatly improved end products.
Colorado Histo-Prep has lived up to its motto of “100% Satisfaction.” I look forward to our business relationship and certainly recommend the company to anyone that may have need of histology services.
Sincerely,
Peter G. Walker
Senior Fish Pathologist
Colorado Division of Wildlife
Trudeau Institute, Inc.
January 31, 2002
To Whom It May Concern:
For the past 6 years I have used the histological services of Colorado Histo-Prep, located in Fort Collins, Colorado, to conduct the processing of mice lung tissue infected with Mycobacterium tuberculosis and M. avium bacteria. The work has included trimming, embedding, microtoming and staining with H&E. In addition the company also performed special stains such as Acid Fast for most of these studies.
Although I have had other resources available for processing formalin fixed tissue, I have chosen to use the services of Colorado Histo-Prep because of rapid turn around time, reproducible results and attention to detail by the staff.
I found the services of Colorado Histo-Prep to be of excellent quality as well as very timely. The staff are very receptive, accommodating and adaptable to our special requests. These qualities have expedited our studies and publications.
Faithfully,
Andrea Cooper, Ph.D
Associate Member
Trudeau Institute, Inc.
I00 Algonquin Ave.
Saranac Lake, NY 12983