Comments on posting from Mark Chavez:
I had previously addressed various issues raised in postings from Mark Chavez. This issue about enhancement of mortality due to enhanced toxicity of endotoxins is a new issue.
I need to study the full details of the animal study and details of experiment before commenting on the quality of the study and validity of the conclusions. BUT LET US ASSUME THAT ALL THAT THEY SAY IS TRUE. IT IS STILL A NON ISSUE FOR MOST SITUATIONS WHERE CELL FREE HB WILL BE USED.
(1) There are 12 millions blood transfusions in USA per year.
(2) In my estimation, the number of patients in whom there is need for transfusions and have endotoxin related severe septicemia may not amount to more than 5000 per year.
(3) Cell free Hb has half life of appr.24 hrs, so people with chronic transfusion need may not benefit from cell free Hb, till long half life products are put in use. Let us estimate that cell free Hb will be suitable for 5 million blood units substituions. So, even if 5000 were excluded from 5 million, that still leaves 99.9% of market, where this scenerio does not apply.
(4 Clinically also this is a non issue: Cell free Hb has been used in more than 3000 patients so far in trial settings. I am sure none of the study patients/volunteers had endotoxin septicemia. Baxter, Northfield use cell free Hb only. Their Hb is dervived from expired Human blood. Nobody has reported such an event. DO YOU THINK FDA WILL ALLOW SUCH TRIALS TO GO ON? Isn't it surprising that nobody has criticized Baxter for studies using cell free Hb from expired Human blood? Somatogen has genetically engineered Hb solution that has the advantage of being available in abundance (no constraints of getting commercial quantities of expired Human blood), does not come from Human blood with fear of blood transmitted diseases, comes with Presbyterian mutation that delivers Oxygen better than natural Hb.
Why did Lilly pull out? I have heard several reasons. Off course, I have no direct connection to Lilly decision makers. HOWEVER, I CAN TEL YOU THAT IF LILLY HAD ANY SAFETY CONCERNS, THEY HAVE TO SPELL IT OUT AND ALSO INFORM FDA. IF THEY DON'T, THEY COULD BE LIABLE FOR HUMONGOUS LIABILITY AND FDA PENALTIES. WHEN LILLY HAS DECIDED TO GET OUT, WHY DO THEY HAVE TO PROTECT SOMATOGEN AND NOT MAKE THEIR SAFETY ISSUES PUBLIC?
But what did Lilly say? Lilly was conducting trial using Optro in patients with elective surgery. Lilly said they had hard time accruing patients for this trial. They concluded that there is not enough demand for such product, to justify funding the ongoing studies for THIS INDICATION. Lilly is right. In most elective surgeries, very few doctors use blood. When Lilly designed trial, they should have done their homework. As a Chief of Hematology and Internal Medicine Dept., I know this and Lilly should have known this. Main use of Optro will be in patients with Trauma, Emergencies or Open Heart surgeries not in elective surgeries. Anyway, Lilly said that they are interested in exploring other Hb molecules that Somatogen is developing(longer half life). Neither Lilly nor FDA have expressed any concerns about safety of Optro.
Under the previous agreement, Lilly was to make milestone payments, fund 50% of cost of ongoing studies and be responsible for 100% 0f manufacturing costs. This was in exchange for world wide marketing rights for Optro (except USA and Scandinavia). Lilly may have felt that they were bearing most of the expenses and risks under the agreement but were excluded from the most lucrative US markets.
In my several conversations in last few weeks, Somatogen has said that
they are continuing to discuss the partnership with several large corporations, but would not finalise any agreement till results of ongoing Optro trials in Open Heart patients are published. Wise move.
Once positive results are published, the value of company and the product goes up, giving better bargaining position.
Somatogen has been a frustrating experience to all of us. Market, Science and rationale do not always go togather. We know of may stocks that sky rocketed with recommendations from market gurus; Netscape, Spyglass, Optical Cable, Ancor etc. Where are these stocks? And what about stocks that rose from Ashes of cremation by market gurus?: Western digital, AMD, Quantum, Micron Technology?
I can only say that genetically engineered Hb (Optro) is one of the Best that science has ever invented. I have no way of predicting when and if Optro will be approved. I am just an investor like anybody else. However, as a Hematologist, I understand the product a little more. I have not sold any of mine, but bought more between $4.50 and 5.50. Who knows? I may be making a mistake. I am a scientist, not a Wall street wizard. IMHO it is because of this yo yo situation and frustrations that Somatogen is trading around 6 instead of 60 or 100. If and when Optro comes to market, Somatogen definitely has more earning potential than Netscape & Spyglass combined,(besides a blessing to Humanity)
B.H. Barai MD
Hematologist
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