Hi all, great news about GNBT/NGIO! We have a lot
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Posted On: 10/07/2020 8:57:35 PM
Hi all, great news about GNBT/NGIO! We have a lot to look forward to and I cannot wait to see Joe up on Fox business or other major outlets providing insights on the safety and effectiveness profile of the Ii-key peptides.
Someone asked a question about what constitutes “development?” It would be a great question for the conference call to have that pathway be highlighted. I’m thinking that by development costs, it is all costs involved: (for example)
1. Identifying peptide chains
2. Testing peptides
3. All regulatory costs in gaining pre-IND and IND approvals
4. Costs for trials in any applicable country and for targeted populations
5. Educational awareness and marketing support costs
6. MFG costs
7. Logistics costs
of GNBT BK looks like it will cover country-specific costs for registration and regulatory costs and own the regulatory asset within those countries as well as the regulatory burden.
9. Licensing costs
Some time ago, GNBT put out a flow chart that may have described most of this pathway with a timeline. If someone has that available, I think it was the end of July. It may be material to review it at this time.
My thought is that BK is just the beginning and the costs will be shared by all partners of NGIO worldwide and that this is a repeatable blueprint that NGIO can use worldwide into developed and less developed countries. Many of us think based upon the USA and North America, but the better market when a mandatory vaccine is concerned is abroad. I believe this information when combined with the peptide results will finally garner the attention that GNBT has needed, and they will be ready to deliver.
Overall this is great news, and the move into other populations aside from adults is a great one that will provide niche success but as we have seen before within the medical device community if it is safe for the more vulnerable populace and II-key can boost based upon who is taking it, it may gain more favor in the adult population as a better choice.
Someone asked a question about what constitutes “development?” It would be a great question for the conference call to have that pathway be highlighted. I’m thinking that by development costs, it is all costs involved: (for example)
1. Identifying peptide chains
2. Testing peptides
3. All regulatory costs in gaining pre-IND and IND approvals
4. Costs for trials in any applicable country and for targeted populations
5. Educational awareness and marketing support costs
6. MFG costs
7. Logistics costs
of GNBT BK looks like it will cover country-specific costs for registration and regulatory costs and own the regulatory asset within those countries as well as the regulatory burden.
9. Licensing costs
Some time ago, GNBT put out a flow chart that may have described most of this pathway with a timeline. If someone has that available, I think it was the end of July. It may be material to review it at this time.
My thought is that BK is just the beginning and the costs will be shared by all partners of NGIO worldwide and that this is a repeatable blueprint that NGIO can use worldwide into developed and less developed countries. Many of us think based upon the USA and North America, but the better market when a mandatory vaccine is concerned is abroad. I believe this information when combined with the peptide results will finally garner the attention that GNBT has needed, and they will be ready to deliver.
Overall this is great news, and the move into other populations aside from adults is a great one that will provide niche success but as we have seen before within the medical device community if it is safe for the more vulnerable populace and II-key can boost based upon who is taking it, it may gain more favor in the adult population as a better choice.
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