GNBT has been declining with low volume as a SHELF was filed last December (no shares have been offered) and the company prepares for a Phase III trial of Oral-lyn. I have posted the results (as seen in presentation abstracts) of two Phase II trials of Oral-lyn on the digitaltradz.com board. (I post a lot of finds there that relate to GNBT.) I believe that the results will be properly PR'd at the Amer Diab sessions late June. The CEO told me that last Oct, and it still appears to be the plan. Now we know Oral-lyn works, as the one study shows a superior effectt when compared to injections. Both show a lowering of HBA1c levels that are comparable, or superior, to injectable insulin. The 100 day study has the final levels of the Oral-lyn group down to 6.1. That's really good. 
Recent comments by the CEO are of interest. In the R & R webcast last week, Ms Gluskin spelled out plans for an upcoming 35 center Phase III trial that will be worldwide. We din't realize the scope of the upcoming trial and I found that to be very good news. Also, Phase IV trials are being planned in L America and the Miidle East where the Ecuadrian dossier for Oral-lyn approval is accepted and only these marketing trials required. These comments were made May 11th 2007 on an online interview with CEOCast.
Last week at an R & R webcast event in Monaco Ms Gluskin made other statements regarding the 35 center worldwide trial and perhaps enlightening remarks about Cardinal/Blackstone Venture. Cardinal Health has been making Phase III batches of Oral-lyn as per the clinical trials manufacturing agreement of June 2006. The agreement was further ammended and signed in feb 2007- as per SEC filings. Cardinal divested this "PTC" contract manufacturing division to Blackstone recently. **(Blackstone themselves may have an IPO soon.)** Cardinal/Blackstone has not only paid for the Oral-lyn filling equipment needed to fill the product as per the trial agreement, but expanded the equipment investment to allow for the filling of 25 million units per year. That's a heck of a lot of Oral-lyn for a trial of 250 to 500 patients! Ms Gluskin, at the webcast event, stated that the cost is ZERO to Generex. Something is doing here with Cardinal/Blackstone. Just a guess on why this big investment for a small deal. Ms Gluskin said it is a possibility when explaining the realtionship. Perhaps contract manufacturing amnd distribution rights post US and Canadian approval. Ms Gluskin said it is a possibility when explaining the relationship. I see that this Cardinal/Blackstone contract manufacturingdivision currently offers nasal, inhalable, and oral pill delivery choices to the biotechs and Pharmas it serves. Did they just purchase the equipment to add buccal cavity? Keep an eye on any developments and tuck the thought away.
I've been long on GNBT for a long while. Just building a position and waiting as these trials and the regulatory process is long and drawn out. That's why this sector requires the most patience for a LONG and many bail out. Understandable. But the SHM is May 29th. The ADA sessions are June 29th. Keep your eyes on GNBT, because we all know the biggest gains in biotechs are during the Phase III process. Guess I'm locked and loaded.
You chart readers can find good entry spots, but just keep your eyes open. jmo
rjs9787
Recent comments by the CEO are of interest. In the R & R webcast last week, Ms Gluskin spelled out plans for an upcoming 35 center Phase III trial that will be worldwide. We din't realize the scope of the upcoming trial and I found that to be very good news. Also, Phase IV trials are being planned in L America and the Miidle East where the Ecuadrian dossier for Oral-lyn approval is accepted and only these marketing trials required. These comments were made May 11th 2007 on an online interview with CEOCast.
Last week at an R & R webcast event in Monaco Ms Gluskin made other statements regarding the 35 center worldwide trial and perhaps enlightening remarks about Cardinal/Blackstone Venture. Cardinal Health has been making Phase III batches of Oral-lyn as per the clinical trials manufacturing agreement of June 2006. The agreement was further ammended and signed in feb 2007- as per SEC filings. Cardinal divested this "PTC" contract manufacturing division to Blackstone recently. **(Blackstone themselves may have an IPO soon.)** Cardinal/Blackstone has not only paid for the Oral-lyn filling equipment needed to fill the product as per the trial agreement, but expanded the equipment investment to allow for the filling of 25 million units per year. That's a heck of a lot of Oral-lyn for a trial of 250 to 500 patients! Ms Gluskin, at the webcast event, stated that the cost is ZERO to Generex. Something is doing here with Cardinal/Blackstone. Just a guess on why this big investment for a small deal. Ms Gluskin said it is a possibility when explaining the realtionship. Perhaps contract manufacturing amnd distribution rights post US and Canadian approval. Ms Gluskin said it is a possibility when explaining the relationship. I see that this Cardinal/Blackstone contract manufacturingdivision currently offers nasal, inhalable, and oral pill delivery choices to the biotechs and Pharmas it serves. Did they just purchase the equipment to add buccal cavity? Keep an eye on any developments and tuck the thought away.
I've been long on GNBT for a long while. Just building a position and waiting as these trials and the regulatory process is long and drawn out. That's why this sector requires the most patience for a LONG and many bail out. Understandable. But the SHM is May 29th. The ADA sessions are June 29th. Keep your eyes on GNBT, because we all know the biggest gains in biotechs are during the Phase III process. Guess I'm locked and loaded.
You chart readers can find good entry spots, but just keep your eyes open. jmo
rjs9787
