Welcome, Guest
Username: Password: Remember me
General
  • Page:
  • 1

TOPIC: Plus Therapeutics

Plus Therapeutics 17 Jul 2019 19:59 #13036

  • franshei
  • franshei's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 790
  • Thank you received: 103
Before my silence on this board, many of my postings were influenced by Tiago Girao. Obviously he had been very optimistic (as he said many times that he would not give up his hopes on the company), till it had become obvious that he was wrong. I still regard him a friend.

I did mention to Tiago that CYTX would probably give up the entire stem cell medical device business and change its name to become a pharma. I think Rodney and many others thought the company would relocate to San Antonio.

I am very, very surprise that the company would also give up liposomal doxo, unless there is something has really gone wrong. It took 2 plus years after multiple failures to validate the San Antonio manufacturing plant. I think they may have started the liposomal manufacturing not too long ago and I think they could not even go beyond a laboratory scale production - it is very likely that the real stability tests are yet to start. I have recently met Abu Alam of Akorn recently and he felt that CYTX may not have the know how to do commercial liposomal pharmaceutical preparation. Taiwan Liposome has its ANDA of liposomal doxo sitting on the desk of the EU FDA for more than one year and yet the approval pathway is still considered very murky. Avi Yacobi of Taro, a part of Sun Pharma, is really a world expert in pharmaceutics and I do not think he is really interested in a similar EU submission. Alam really think this liposomal doxo project is almost 20 years too old to generate much excitement. I did express my opinion to CYTX. (I also told them that Lypomed /John Kapoor had an annual revenue of over $ 100 million in the 1980/1990s with several dozens of generic injectibles, but we never made money in almost 10 cytoxic drugs.)

I think even a company like ATHENEX would not be interested in this project, as the buyer would have to start the project from scratch - the newly prepared liposomal doxo may not be the same as the one made and tested (bioequivancy) by AYA.

The liposomal taxol project is really a very, very high risk project. Hendrick is not a medical oncologist and there is no in house oncology know how to run such a project, while the US IND has yet to be filed. Preparation of a phase 2 protocol in the second half of 2019 is really a step to set up a preIND meeting with the FDA. Based on Hedrick's remarks on July 15, the IND filing with a completed drug master file is still a year away.

A group of Chinese medical doctors have tested liposomal taxol in the past 10 years. The drug is safe but the efficacy in non small lung has been disappointing. The drug may work in small cell lung (smokers) but there is no basis to expect convincing phase 2 success. Genta (Ray Warrel) had also tried to find a clnical miracle to save the company through new taxol and it failed (Ray is really a great medical oncologist from MSKCC). I did express my opinion to the company.

With $ 10 million debt and limited cash (maybe only $ 4-5 million), how long can PSTV live onfrom here.
The following user(s) said Thank You: myownhedgefund

Please Log in or Create an account to join the conversation.

Plus Therapeutics 17 Jul 2019 20:14 #13037

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2806
  • Thank you received: 200
Hello franshei...its been a long time. Thanks for the comments.

Please Log in or Create an account to join the conversation.

Plus Therapeutics 17 Jul 2019 20:20 #13038

  • rodney.strongg
  • rodney.strongg's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1307
  • Thank you received: 19

franshei wrote: Before my silence on this board, many of my postings were influenced by Tiago Girao. Obviously he had been very optimistic (as he said many times that he would not give up his hopes on the company), till it had become obvious that he was wrong. I still regard him a friend.

I did mention to Tiago that CYTX would probably give up the entire stem cell medical device business and change its name to become a pharma. I think Rodney and many others thought the company would relocate to San Antonio.

I am very, very surprise that the company would also give up liposomal doxo, unless there is something has really gone wrong. It took 2 plus years after multiple failures to validate the San Antonio manufacturing plant. I think they may have started the liposomal manufacturing not too long ago and I think they could not even go beyond a laboratory scale production - it is very likely that the real stability tests are yet to start. I have recently met Abu Alam of Akorn recently and he felt that CYTX may not have the know how to do commercial liposomal pharmaceutical preparation. Taiwan Liposome has its ANDA of liposomal doxo sitting on the desk of the EU FDA for more than one year and yet the approval pathway is still considered very murky. Avi Yacobi of Taro, a part of Sun Pharma, is really a world expert in pharmaceutics and I do not think he is really interested in a similar EU submission. Alam really think this liposomal doxo project is almost 20 years too old to generate much excitement. I did express my opinion to CYTX. (I also told them that Lypomed /John Kapoor had an annual revenue of over $ 100 million in the 1980/1990s with several dozens of generic injectibles, but we never made money in almost 10 cytoxic drugs.)

I think even a company like ATHENEX would not be interested in this project, as the buyer would have to start the project from scratch - the newly prepared liposomal doxo may not be the same as the one made and tested (bioequivancy) by AYA.

The liposomal taxol project is really a very, very high risk project. Hendrick is not a medical oncologist and there is no in house oncology know how to run such a project, while the US IND has yet to be filed. Preparation of a phase 2 protocol in the second half of 2019 is really a step to set up a preIND meeting with the FDA. Based on Hedrick's remarks on July 15, the IND filing with a completed drug master file is still a year away.

A group of Chinese medical doctors have tested liposomal taxol in the past 10 years. The drug is safe but the efficacy in non small lung has been disappointing. The drug may work in small cell lung (smokers) but there is no basis to expect convincing phase 2 success. Genta (Ray Warrel) had also tried to find a clnical miracle to save the company through new taxol and it failed (Ray is really a great medical oncologist from MSKCC). I did express my opinion to the company.

With $ 10 million debt and limited cash (maybe only $ 4-5 million), how long can PSTV live onfrom here.

/

Franshei, welcome back - it is really great to hear from you - hope all has been well with you and your family.

Please Log in or Create an account to join the conversation.

Plus Therapeutics 18 Jul 2019 03:30 #13039

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3319
  • Thank you received: 1111
Welcome back Franshei from me too. We really missed your pharmacological expertise in the time you were gone.

With $ 10 million debt and limited cash (maybe only $ 4-5 million), how long can PSTV live onfrom here

Yeah- that is what everybody is wondering and considering. Logically speaking giving up the doxo should bring in the cash required for continued development operations, whatever those will be besides taxol. My question to you than would be- assuming everything went more smoothly than you suggested in your post and stability testing would really be completed by October (which we were assuming here), what ball park figure do you think PSTV could achieve in the market for this divestiture?

Just some more comments- the liposomal tech- despite being old- is now reaching folks like myself, who had never heard of it until Cytori acquired Azaya. I raised my serum value of glutathione (the strongest human anti-oxidant) tremendously in no-time with the tech and for me it is a prime marker for cardiac risk and a whole lot of other health risks (I will entertain you folks on that score sometime soon).
Second- the fact that Hedrick is still CEO and John Fraser still Chief-science officer (both were instrumental at StemSource acquired in 2002 by Cytori) tells me they have more on their sleeves besides oncology.

Please Log in or Create an account to join the conversation.

Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Plus Therapeutics 18 Jul 2019 06:03 #13040

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2806
  • Thank you received: 200
I guess another question would be is could they even sell this drug before the cash runs out ?
Again the burn rate question arises.
They still need to keep $1.5 million in reserve for Oxford.

Please Log in or Create an account to join the conversation.

Plus Therapeutics 18 Jul 2019 07:15 #13041

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3319
  • Thank you received: 1111

myownhedgefund wrote: I guess another question would be is could they even sell this drug before the cash runs out ?
Again the burn rate question arises.
They still need to keep $1.5 million in reserve for Oxford.


Yeah - we all know I guess- but every day passing without the reverse split being announced, gives me a tiny bit of hope. I do re-call last times around they decided that straight after the ASM both at the first one (mid 2016(?)) and last year. Basically, since they are all around for that meeting anyway. And August is just around the corner.

Please Log in or Create an account to join the conversation.

Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Plus Therapeutics 18 Jul 2019 08:13 #13042

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2806
  • Thank you received: 200
With the delay in RS approval my guess is August as well for the announcement this time around.

Please Log in or Create an account to join the conversation.

  • Page:
  • 1
Time to create page: 0.120 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites