How much does a Phase 2 Liver trial cost????
Maybe Dr. Ross Weber Thompson and Argwala are in Cahoots with Sinopharm.... Making remarks like Perfect etc.... Now Extensive economic and Social benefit along with many other indications the drug will be applicable.
They signed off on the remarks that PV-10 could be used for other indications and said "which will provide EXTENSIVE" economic and social benefit".... They could have left that stuff out but felt compelled to but their reputation on the line IMO....
Sinopharm and their Scientist signed the MOU.... So maybe they have seen some evidence that gives them the confidence for such remarks.
How so???My understanding is that 50-60% don't respond to current therapies??? The only choice is PV-10 if you have lesions that keep coming back on your skin and they already tried surgery. The other choice is die or try chemo or PV-10 and kill the lesions before they grow bigger and spread through the body. If PFS is 3 months for chemo then why not kill the trial and inject all the patients lesions with PV-10 with a much longer PFS and complete response.
In terms of Options exercise looks like Night and Day.... 3.6 Million worth of stock bought or exercised by the CTO alone over the last 5 years. 1.8M spent on exercised over the last 6 months by 3 out of the 4 horseman as you like to call them. GTXI doesn't have much options exercise or Executives partaking in Private Placements of the companies stock. I think you need to do more due diligence before throwing accusations.
After more thought it appears Dr. Ross will be doing his own combination studies. Also he alluded to this in his last published research.
seems like the dr. thinks folks will benefit.... also allows folks that are not candidates for phase 3 get treatment.
CLINICAL TRIAL SUMMARY
MDACC Study No: 2014-0065 (clinicaltrials.gov NCT No: NCT01260779)
Title: Open Label Expanded Access for Investigational Use of PV-10 in Patients Who are not Eligible for an Existing PV-10 Clinical Trial, for Whom There is no Comparable or Satisfactory Alternative Therapy and Whom, in the Opinion of the Investigator, May Benefit from PV-10 Administration
Principal Investigator: Merrick I. Ross
Treatment Agent: PV-10
Study Status: Open
Study Description: The goal of this study is to allow access to PV-10 for patients who are not
eligible to receive the drug on another study. Another goal of this study is
to learn if PV-10 can help to control the disease. The safety of the drug will
also be studied.
But maybe he wasn't allowed to wait.... material info...???
He could have taken the 370K he paid for Fed/state tax for exercising and used that to exercise shares now... The company would have gotten the 370K instead of the Gov't.... just saying
While no standardized surgical approach to all patients with locally recurrent melanoma has been established, treatment guidelines have been developed based on clinical trials in patients selected by the extent and specific anatomic site of disease recurrence. The realization that local recurrence is not simply the result of inadequate surgical excision but is in fact an outward manifestation of the biological aggressiveness of the primary melanoma has lead to a more rational approach to the treatment of these patients.
Complete surgical resection with primary wound closure is the most straightforward means of treating single recurrent lesions. Patients with multiple subcutaneous metastases grouped within a single site can similarly be treated with wide local excision with skin grafting or flap closure as necessary for wound coverage. While wide resection margins are not as well defined in the resection of locally recurrent disease as they are in the treatment of primary cutaneous melanoma, recurrent lesions should be resected with a margin of normal tissue.
Unfortunately, despite complete surgical resection of multiple cutaneous metastases, further local and regional recurrence may occur in up to 67% of patients with locally recurrent malignant melanoma and is strongly associated with subsequent disease progression. As many as 70–82% of such patients ultimately succumb to distant metastases. Although systemic chemotherapy in the adjuvant setting is rarely effective, systemic immunotherapy, in the form of Interferon alpha-2b (Intron A) or a variety of experimental melanoma vaccines, may have a role in the treatment of patients subsequent to complete surgical resection of locally recurrent melanoma. The effectiveness of such modes of immunotherapy in improving survival in these patients, remains unproven.