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Posted On: 06/10/2022 5:10:17 PM
Post# of 148908
I have been thinking about the new strategy by mgmt, which is very little communication through PRs and direct to shareholders. The only catalysts we have is finishing the BLA and getting the formal acceptance from the FDA. Dr Reckner should be close to getting the data straitened out so the final submission should be in the next few weeks, possible a month or two.
As for other indications, It was very clear in the 1st quarter CC that all of these are in the "get a partner to take the next steps" phase. As much as we like being informed of what is going on, the audience for this is the actual partners, not us investors. They are only following the SEC requirements for us. However, partners really want to see what is the potential - they know the steps that need to be taken to finish a phase 3 trial etc.. they just need to know how much market each indication is. The p2 trial data is used to see who needs the drug and having data that shows one dose amount works and double it works less shows that either the dosing is figured out (we don't have to assume that if 700 is twice as good as 350, then 1400 must be even better) Or, the patients in the trial are varied in various health condition to show what leronlimab's true potential for when to use it and on who. This forms what the p3 trial is going to target. This also sets the % of the market that will benefit so the price tag gets set. Partners need to know what they get for their money before they jump in.
In all of my research on biotech buyouts, the buyer started as a partner. the relationship is well established. The partner has a very good idea of what they are buying. they will pay for trials to answer the lingering questions about the drug. once they know, they buy. to them the BLA is not easy but not a step that is limited by funding. they already have too much invested to back away at this point.
The announcement of any partnership is the catalyst that will change this in a huge way. the HIV BLA hopefully does not become the revenue to pay for further trials because they could not form a partnership. the BLA needs to legitimize leronlimab for future FDA approvals - paving the way so partners see that this will get approved for other indications. We are right at the tipping point for these catalysts, the timeline to start and conduct the next trials is not a timeline for the stock price movement.
As for other indications, It was very clear in the 1st quarter CC that all of these are in the "get a partner to take the next steps" phase. As much as we like being informed of what is going on, the audience for this is the actual partners, not us investors. They are only following the SEC requirements for us. However, partners really want to see what is the potential - they know the steps that need to be taken to finish a phase 3 trial etc.. they just need to know how much market each indication is. The p2 trial data is used to see who needs the drug and having data that shows one dose amount works and double it works less shows that either the dosing is figured out (we don't have to assume that if 700 is twice as good as 350, then 1400 must be even better) Or, the patients in the trial are varied in various health condition to show what leronlimab's true potential for when to use it and on who. This forms what the p3 trial is going to target. This also sets the % of the market that will benefit so the price tag gets set. Partners need to know what they get for their money before they jump in.
In all of my research on biotech buyouts, the buyer started as a partner. the relationship is well established. The partner has a very good idea of what they are buying. they will pay for trials to answer the lingering questions about the drug. once they know, they buy. to them the BLA is not easy but not a step that is limited by funding. they already have too much invested to back away at this point.
The announcement of any partnership is the catalyst that will change this in a huge way. the HIV BLA hopefully does not become the revenue to pay for further trials because they could not form a partnership. the BLA needs to legitimize leronlimab for future FDA approvals - paving the way so partners see that this will get approved for other indications. We are right at the tipping point for these catalysts, the timeline to start and conduct the next trials is not a timeline for the stock price movement.
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