Pharmos is moving alone with Phase III.
Good, to wait for partner is to waste time.
Pharmos will finance itself: sales, credit line, more shares.
Pharmos is planning a 250 to 300 subjects study.
Already, plans are ahead, Multicenter, 30 international centers, and world leaders in trauma, on board. This could take 6 month to recruit, another 6 month for follow up.
Pharmos call it Phase II/III, since it could be expanded if needded to 800, or have the necessary data available.
Decrease disability and faster recovery (decrease morbidity benefit, good for approval)were already statistically significant.
Decrease intracranial pressure, and lack of drop in systemic pressure were proven to have statistical significance.
(surrogates points for approval, meaning each by itself are benefits that if proven could reasonably be a harbinger of general benefit)
Decrease mortality, this was only a trend, statistical significance will required many more patients to prove. It could happen since the population will be more diverse this time with 30 international centers, so the higher mortality expected have more chance of happening. This is the only doubt, but not strictly necessary to be approved in this case if the other benefits are clearly proven.
To design and execute an international, multicenter trial of this kind shows great organizational skills and prestige.
"Partners" are not accepting Aviv proposal, after looking at the data:
1. They are not willing to risk due to mediocre data.
2. Aviv is not willing to give company away.
3. But they are willing to join later (and pay what Aviv is asking) when more data available.
LE-Tobra 2nd trial will not take long, not so expensive, and it seems that Pharmos could move on both drugs (le-t and dexanabinol) showing even more financial strength.
Profits?, this is a development company, profits will come when dexanabinol is ready, increase revenues is enough at this stage. This is another money losing biotech.
All this means, that the share prices are going to be static at best. Neutral. Not moving.
Position: I am a holder, this is a high risk investment, not buying more at this time. |
