Chemistfrog's Comments RSS Syndication from SeekingAlpha.com http://seekingalpha.com/user/399559/comments http://seekingalpha.com/article/1429091/comments?source=feed#comment-18878781 18878781 Wed, 15 May 2013 21:58:19 -0400 http://seekingalpha.com/article/1110331/comments?source=feed#comment-18878651 18878651 Wed, 15 May 2013 21:54:02 -0400 http://seekingalpha.com/article/1429091/comments?source=feed#comment-18834961 18834961 http://seekingalpha.co...

"Paul Nouri - Noble Equity Funds
Have you gotten court dates with any of the other cases yet?
Barry W. Weiner - Co Founder, President, Chief Financial Officer, Principal Accounting Officer, Treasurer and Director
Yes, we have. We are looking to court dates in early November for the New York cases."

"Paul Nouri - Noble Equity Funds
Looking at the Life Technologies court decision, I guess the timing of it becoming finalized is the next 6 to 9 months at this point?"

I think that's it? May have to dig a little for the other (I wrote this a couple of weeks ago). Thanks.]]> Tue, 14 May 2013 23:34:01 -0400 http://seekingalpha.co...

"Paul Nouri - Noble Equity Funds
Have you gotten court dates with any of the other cases yet?
Barry W. Weiner - Co Founder, President, Chief Financial Officer, Principal Accounting Officer, Treasurer and Director
Yes, we have. We are looking to court dates in early November for the New York cases."

"Paul Nouri - Noble Equity Funds
Looking at the Life Technologies court decision, I guess the timing of it becoming finalized is the next 6 to 9 months at this point?"

I think that's it? May have to dig a little for the other (I wrote this a couple of weeks ago). Thanks.]]> http://seekingalpha.com/article/1429661/comments?source=feed#comment-18790801 18790801 Mon, 13 May 2013 21:08:30 -0400 http://seekingalpha.com/article/1409241/comments?source=feed#comment-18606531 18606531 Wed, 08 May 2013 21:48:01 -0400 http://seekingalpha.com/article/1409241/comments?source=feed#comment-18604611 18604611 Wed, 08 May 2013 21:00:41 -0400 http://seekingalpha.com/article/1410291/comments?source=feed#comment-18574301 18574301 Wed, 08 May 2013 09:52:49 -0400 http://seekingalpha.com/article/1381501/comments?source=feed#comment-18276481 18276481
Thanks and best of luck this week!]]> Tue, 30 Apr 2013 13:10:25 -0400
Thanks and best of luck this week!]]> http://seekingalpha.com/article/1381501/comments?source=feed#comment-18249041 18249041
CF]]> Mon, 29 Apr 2013 20:33:11 -0400
CF]]> http://seekingalpha.com/article/1381501/comments?source=feed#comment-18248941 18248941 Mon, 29 Apr 2013 20:31:19 -0400 http://seekingalpha.com/article/1381501/comments?source=feed#comment-18248861 18248861 Mon, 29 Apr 2013 20:29:47 -0400 http://seekingalpha.com/article/1381501/comments?source=feed#comment-18248771 18248771
CF]]> Mon, 29 Apr 2013 20:27:23 -0400
CF]]> http://seekingalpha.com/article/1312701/comments?source=feed#comment-18072041 18072041
Thanks]]> Thu, 25 Apr 2013 08:54:07 -0400
Thanks]]> http://seekingalpha.com/article/1333761/comments?source=feed#comment-17519531 17519531
Thanks for the clarification and please have a nice weekend ahead.
CF]]> Thu, 11 Apr 2013 20:16:34 -0400
Thanks for the clarification and please have a nice weekend ahead.
CF]]> http://seekingalpha.com/article/1327141/comments?source=feed#comment-17427181 17427181
http://bit.ly/10RylPc]]> Tue, 09 Apr 2013 20:23:07 -0400
http://bit.ly/10RylPc]]> http://seekingalpha.com/article/1312701/comments?source=feed#comment-17373801 17373801
Good luck this week,
CF]]> Mon, 08 Apr 2013 17:16:23 -0400
Good luck this week,
CF]]> http://seekingalpha.com/article/1314121/comments?source=feed#comment-17373731 17373731
CF

" With initial enrollment of 163 patients targeted, the company will then perform a sample size re-estimation to determine what number of patients ultimately enrolled would be necessary to have statistically significant results at the trial's conclusion, with a range of 326-652 patients expected. Updates on this final enrollment size will indicate how much longer the trial may take and give an indication about how much more money PLC would require for trial completion."]]> Mon, 08 Apr 2013 17:15:32 -0400
CF

" With initial enrollment of 163 patients targeted, the company will then perform a sample size re-estimation to determine what number of patients ultimately enrolled would be necessary to have statistically significant results at the trial's conclusion, with a range of 326-652 patients expected. Updates on this final enrollment size will indicate how much longer the trial may take and give an indication about how much more money PLC would require for trial completion."]]> http://seekingalpha.com/article/1327141/comments?source=feed#comment-17373611 17373611 securities"

Thanks]]> Mon, 08 Apr 2013 17:13:41 -0400 securities"

Thanks]]> http://seekingalpha.com/article/1327141/comments?source=feed#comment-17373501 17373501 Mon, 08 Apr 2013 17:10:57 -0400 http://seekingalpha.com/article/1312701/comments?source=feed#comment-17192991 17192991
Best of luck....]]> Wed, 03 Apr 2013 20:49:35 -0400
Best of luck....]]> http://seekingalpha.com/article/1314121/comments?source=feed#comment-17140141 17140141 Tue, 02 Apr 2013 21:01:53 -0400 http://seekingalpha.com/article/1314121/comments?source=feed#comment-17122061 17122061 Tue, 02 Apr 2013 14:07:41 -0400 http://seekingalpha.com/article/1305901/comments?source=feed#comment-16963291 16963291
Thanks and best of luck to you.]]> Thu, 28 Mar 2013 20:37:59 -0400
Thanks and best of luck to you.]]> http://seekingalpha.com/article/1153731/comments?source=feed#comment-16938051 16938051
Thoughts??]]> Thu, 28 Mar 2013 11:59:52 -0400
Thoughts??]]> http://seekingalpha.com/article/1301511/comments?source=feed#comment-16889011 16889011
CF]]> Wed, 27 Mar 2013 13:12:26 -0400
CF]]> http://seekingalpha.com/article/1288951/comments?source=feed#comment-16583921 16583921
Yes, the downside does exist and I will keep that in mind. I have stop limits in place but do realize they wouldn't be of any help in a "gap down" type of scenario.

Thanks again for the work and I appreciate the insight. As investors we all have to weigh the risks and ascertain what is truth, partial truth or fiction. You add more information to our arsenal by which we can hopefully make our decisions. Please keep up the good work!
CF]]> Wed, 20 Mar 2013 22:56:49 -0400
Yes, the downside does exist and I will keep that in mind. I have stop limits in place but do realize they wouldn't be of any help in a "gap down" type of scenario.

Thanks again for the work and I appreciate the insight. As investors we all have to weigh the risks and ascertain what is truth, partial truth or fiction. You add more information to our arsenal by which we can hopefully make our decisions. Please keep up the good work!
CF]]> http://seekingalpha.com/article/1263891/comments?source=feed#comment-16210511 16210511
"Although Arrayit could provide a possible means to evaluate the patients experiencing adverse events with regard to OMONTYS and a means to screen future patients, the company should only be considered as a speculative possibility unless more information can be presented by the company."]]> Wed, 13 Mar 2013 00:04:05 -0400
"Although Arrayit could provide a possible means to evaluate the patients experiencing adverse events with regard to OMONTYS and a means to screen future patients, the company should only be considered as a speculative possibility unless more information can be presented by the company."]]> http://seekingalpha.com/article/1242731/comments?source=feed#comment-15897561 15897561
It appears that ATHX support is holding very well, closing today at $1.57. Now we need to see how it holds up on a red market day. ]]> Tue, 05 Mar 2013 23:49:27 -0500
It appears that ATHX support is holding very well, closing today at $1.57. Now we need to see how it holds up on a red market day. ]]> http://seekingalpha.com/article/1234751/comments?source=feed#comment-15897081 15897081 http://1.usa.gov/YbNN6T

F(ab')2 pegylation

After preparation, the F(ab')2 were dialyzed against borate buffer 0.02 M pH 9 before conjugation to PEG using a 3-fold molar excess of PEG (15 nmoles) added to 500 µg (500 µl of a 1 mg/ml solution) of dialyzed F(ab')2 (5 nmoles). After 30 min at room temperature with gentle agitation, F(ab')2 were purified by cation exchange chromatography to remove unreacted PEG and to separate the different F(ab')2 species (nonpegylated, monopegylated and multipegylated F(ab')2). A MacroCap SP column (GE Healthcare) (10.5×1 cm) was used with an AKTÄ system (GE Healthcare) and equilibrated with buffer A (0.02 M acetate buffer pH 5) at a flow rate of 1 ml/min. The reaction mixture was filtered through a 0.2 µm filter and loaded onto the column. After washing the column with 17 ml of buffer A at 1 ml/min, the pegylated F(ab')2 was eluted using successive gradient steps of 12 ml each at 2, 3, 4, 5 and 25% of buffer B (0.02 M acetate buffer pH 5+1 M NaCl) at 1 ml/min. The column was regenerated with 17 ml of buffer B at 1 ml/min. During the chromatography, fractions of 1 ml were collected and the absorbance was monitored at 280 nm. Fractions corresponding to each peak were pooled and analyzed by SDS-PAGE.

Observations: a 3-fold molar excess of PEG was utilized in that particular scenario, noting that it is possible the OMONTYS manufacturing may also incorporate excess levels of PEG (nothing alarming about that as long as it's removed before the final product goes out the door). Cation-exchange chromatography was used in the above example (plausible on a larger scale with larger production-scale batches but with much much bigger cation-exchange columns).

Possibilities:
Not enough PEG was utilized (for several batches/lots, it could be because lower purity PEG was utilized, but with the lower purity not compensated for by using more, the pegylation reaction would not have yielded 100% desired final product but would rather have some lower molecular weight peptidic ESA unreacted, which could trigger anaphylactic shock due to immunogenicity.

Too much PEG was utilized, which in itself can trigger hypersensitivity also. If this is sufficiently removed, no problems. However, if the cation exchange or other means of excess PEG removal was inadequate due to processing issues or due to higher levels of PEG than the system can adequately clean up, the PEG could carry into the finished product in PEG form, or produce other undesirable products depending on what else is in the solution/mixture.]]> Tue, 05 Mar 2013 23:36:18 -0500 http://1.usa.gov/YbNN6T

F(ab')2 pegylation

After preparation, the F(ab')2 were dialyzed against borate buffer 0.02 M pH 9 before conjugation to PEG using a 3-fold molar excess of PEG (15 nmoles) added to 500 µg (500 µl of a 1 mg/ml solution) of dialyzed F(ab')2 (5 nmoles). After 30 min at room temperature with gentle agitation, F(ab')2 were purified by cation exchange chromatography to remove unreacted PEG and to separate the different F(ab')2 species (nonpegylated, monopegylated and multipegylated F(ab')2). A MacroCap SP column (GE Healthcare) (10.5×1 cm) was used with an AKTÄ system (GE Healthcare) and equilibrated with buffer A (0.02 M acetate buffer pH 5) at a flow rate of 1 ml/min. The reaction mixture was filtered through a 0.2 µm filter and loaded onto the column. After washing the column with 17 ml of buffer A at 1 ml/min, the pegylated F(ab')2 was eluted using successive gradient steps of 12 ml each at 2, 3, 4, 5 and 25% of buffer B (0.02 M acetate buffer pH 5+1 M NaCl) at 1 ml/min. The column was regenerated with 17 ml of buffer B at 1 ml/min. During the chromatography, fractions of 1 ml were collected and the absorbance was monitored at 280 nm. Fractions corresponding to each peak were pooled and analyzed by SDS-PAGE.

Observations: a 3-fold molar excess of PEG was utilized in that particular scenario, noting that it is possible the OMONTYS manufacturing may also incorporate excess levels of PEG (nothing alarming about that as long as it's removed before the final product goes out the door). Cation-exchange chromatography was used in the above example (plausible on a larger scale with larger production-scale batches but with much much bigger cation-exchange columns).

Possibilities:
Not enough PEG was utilized (for several batches/lots, it could be because lower purity PEG was utilized, but with the lower purity not compensated for by using more, the pegylation reaction would not have yielded 100% desired final product but would rather have some lower molecular weight peptidic ESA unreacted, which could trigger anaphylactic shock due to immunogenicity.

Too much PEG was utilized, which in itself can trigger hypersensitivity also. If this is sufficiently removed, no problems. However, if the cation exchange or other means of excess PEG removal was inadequate due to processing issues or due to higher levels of PEG than the system can adequately clean up, the PEG could carry into the finished product in PEG form, or produce other undesirable products depending on what else is in the solution/mixture.]]> http://seekingalpha.com/article/1234751/comments?source=feed#comment-15895831 15895831
"With the use of Nektar's advanced PEGylation technology, the properties of therapeutic agents, such as Hematide(TM), can be enhanced by increasing drug circulation time in the bloodstream, decreasing immunogenicity, and reducing dosing frequency. Nektar proprietary technology uses advanced conjugation chemistry and techniques to attach polyethylene glycol polymers to therapeutic agents."

So, if PEG was of lower purity than actually stated (for example 90% instead of 98%), than the pegylation reaction wouldn't be efficient and yield 100% peginesatide. If that is the case, then let's say that about 5% of the peptidic ESA is still in the lower molecular weight form. If that is the case, there may be some induced immunogenicity which could possibly trigger the anaphylactic shock and other adverse events? See the following link about immunogenicity and anaphylactic shock: http://bit.ly/YMv8i2

In other words, excess PEG could be the culprit as could a shortage... Too much PEG left over in the final product could cause hypersensitivity while not enough could leave enough to leave lower molecular weight peptidic ESA unreacted which could induce immunogenicity and also trigger the AE's.

This is just conjecture and should not yet be construed as a "smoking gun".]]> Tue, 05 Mar 2013 23:00:31 -0500
"With the use of Nektar's advanced PEGylation technology, the properties of therapeutic agents, such as Hematide(TM), can be enhanced by increasing drug circulation time in the bloodstream, decreasing immunogenicity, and reducing dosing frequency. Nektar proprietary technology uses advanced conjugation chemistry and techniques to attach polyethylene glycol polymers to therapeutic agents."

So, if PEG was of lower purity than actually stated (for example 90% instead of 98%), than the pegylation reaction wouldn't be efficient and yield 100% peginesatide. If that is the case, then let's say that about 5% of the peptidic ESA is still in the lower molecular weight form. If that is the case, there may be some induced immunogenicity which could possibly trigger the anaphylactic shock and other adverse events? See the following link about immunogenicity and anaphylactic shock: http://bit.ly/YMv8i2

In other words, excess PEG could be the culprit as could a shortage... Too much PEG left over in the final product could cause hypersensitivity while not enough could leave enough to leave lower molecular weight peptidic ESA unreacted which could induce immunogenicity and also trigger the AE's.

This is just conjecture and should not yet be construed as a "smoking gun".]]>