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Re: Gentlemen Prefer Bonds post# 568

Saturday, 11/21/2020 2:49:54 PM

Saturday, November 21, 2020 2:49:54 PM

Post# of 933
Except that Quadramet is not Cyclosam.

Here's a quote from Journal of the National Cancer Institute, Volume 96, Issue 21, 3 November 2004

While that is all highly encouraging, a contractual prohibition effectively stops Cytogen from sponsoring a multiyear, large-scale clinical trial that could examine whether Quadramet enhances long-term survival. Dow Chemical has licensed Quadramet to Cytogen only for bone-pain palliation, giving another company—Seattle-based NeoRx—myeloablation rights to a newer radiopharmaceutical, STR (166-holmium DOTMP).


Quadramet was licensed from a patent issued to Dow Chemical. It is patent number 4898724, that expired in 2011.

The list of Cyclosam patent applications is Exhibit A in the SEC filing of the agreement between IGL and QSAM. The only two issued patents are 10172965 and 10596277. They were both applied for and granted to IGL Pharma Inc.

Quadramet is Samarium-153 EDTMP while Cyclosam is Samarium-153 DOTMP. Although they both contain Samarium-153, they are different drugs so the FDA approvals of Quadramet do not cover Cyclosam.

The National Institutes of Health show only one clinical trial for Cyclosam. https://clinicaltrials.gov/ct2/show/NCT03612466 Here is the relevant bit about study timing:


Note that their estimate for completion was September 2023, but provided the trial started this month. The November 10 press release said:

CycloSam is expected to go into Phase 1 clinical trials in the first half of 2021

(pushed back already from the Q1 prediction made in the September 10 PR).

A six month delay in trial start would push completion to 2024.

There "is no way Phase 1 trials will be three years"? Then why is that exactly what the NIH and FDA have been told?

"Cyclosam is already approved by the FDA"? Not according to the FDA approved drug database

Speaking of delays, here's some history with Chris Nelson as president of Cyclone. In December 2011 they did an open house for shareholders. The powerpoint slides were filed with the SEC. Chris Nelson presented a timeline for the following two years:



That was nine years ago. Of all those boxes, only two were completed in some fashion:
1) The Raytheon delivery was supposed to be two complete Mark V engines of 100 hp, but in June 2012 they got two "Manta Ray 36" engines, extremely stripped down Mark Vs claiming to make 36 hp. These two engines were never heard from again.
2) The Army delivery was one smaller engine that occurred in May 2014. Cyclone never released any information about this engine actually running, and it was never heard from again.

Every other box on that chart has yet to be completed.

But Chris Nelson was happy to tell investors that it was all going to be done by seven years ago.
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