Outlook Therapeutics FDA Rejection

Voyager2002

masonic said:

robertbanking said:

I kindly wondered as a private investor, how you could hopefully increase your chances of success that a biotechnology company would get the manufacturing process correct please? For instance would having a Chief Operating Officer that has experience in CMC management be helpful please? Lastly could you check reviews and details of the outsourced company they used for the manufacturing program please? If you kindly had any thoughts on this it would mean the world to me and i would be forever grateful. Thanks very much for being a wonderful and helpful person Masonic. Very best wishes to you.  

Major investors in a biotech will generally be able to meet with the principals and discuss in detail any aspect of the project. They often engage relevant subject matter experts to do due diligence, wherein they are granted access to a data room containing the relevant information. A private investor doesn't have those sort of resources at their disposal, so have to manage with the very heavily redacted public disclosures made by the company. Looking at the management team and their track record might give you some insight, but every project is different and you can't really know as an outside observer exactly what is going on at a nuts and bolts level, or whether the team are capable of overcoming whatever issues they face. Even with the full information, investors back the wrong horse often enough. It is a high risk sector with many things that can go wrong at each stage of bringing a drug to market.

As an illustration of this, see the long thread from a few years ago about investing in Biotech. One of the companies that featured in that discussion, and in which I invested, gave me a spectacular result -- a 99.99 per cent loss! Eight thousand dollars turned into a few cents.

LHW99

Sometimes Google can help if you search for the company / product names.

You have to work very carefully to get the search to return the type of results you want, and omit the unuseful - worth reading up on search syntax. It can provide information on eg legal disputes / cases (eg metal to metal hip joints) etc. - too many are not ideal!

You can also look for patents, search for published papers etc.

Helps if you have some sort of (bio)science background to interpret the information.

robertbanking

Thank you very much for your help with this masonic you are a star. I have always seen lots of Biotechnology stocks getting approval for drugs and doing well, however there is alot more that don't succeed. It seems helpful if you have some inside knowledge to the workings of a Biotechnology company. It still seems an unfair market that those large private investors get access to more information, its not really a fair market if the small private investor has to rely on the heavily redacted public statements.   

Can i kindly please ask lastly a final thought in my mind, i have read that manufacturing for instance a once daily oral pill for certain diseases is alot easier to manufacture, than for instance monoclonal antibodys that can be targeted for a range of diseases. Can i kindly please ask if there is any truth to this and whether it would be easier to meet the FDAs requirements than for instance other delivery mechanisms such as IV please? If you kindly had any thoughts on this it would be highly appreciated. I really appreciate your time with this masonic, i love learning all the time and you have been a great help. Have a wonderful evening and all the very best to you. Good luck with your future endeavours. 

masonic

robertbanking said:

Can i kindly please ask lastly a final thought in my mind, i have read that manufacturing for instance a once daily oral pill for certain diseases is alot easier to manufacture, than for instance monoclonal antibodys that can be targeted for a range of diseases. Can i kindly please ask if there is any truth to this and whether it would be easier to meet the FDAs requirements than for instance other delivery mechanisms such as IV please? If you kindly had any thoughts on this it would be highly appreciated. I really appreciate your time with this masonic, i love learning all the time and you have been a great help. Have a wonderful evening and all the very best to you. Good luck with your future endeavours. 

Biologics tend to have more complex formulation considerations as they are less stable than a typical small molecule drug and may also have other issues such as protein aggregation. However, formulation of a drug that's suitable for oral dosing can be very simple (drug substance + filler in capsule/tablet), or more difficult (involving micronisation, spray drying, solubilising excipients, extended release formulation, enteric coating etc). But even with what appears to be a tried and tested process for an oral drug product, things can go wrong in manufacturing. There was the classic case of Ritonavir, which had to be temporarily withdrawn from the market due to the formation of a more stable but less soluble crystal form during manufacture, causing a PR disaster for the then Abbott, where tens of thousands of AIDS patients were left without treatment. The story is nicely described in the following open access article, along with some other drugs that suffered similar issues: https://onlinelibrary.wiley.com/doi/full/10.1002/anie.201410356

DiamondLil

shortseller09 said:

It would mean the world to me and I would be forever grateful if you could just speak normally.

SkyNet speaks as directed; just ask Arnie.