I know we expect to get P top line within the next
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Posted On: 02/13/2018 12:26:38 PM
I know we expect to get P top line within the next handful of weeks, but other than that I am pretty sketchy as to the realistic timeline we can expect for further trial progress or news forthcoming from the company. Have no clue as to length of time needed for :
FDA to grant Expanded Access/Compassionate Use designation and exactly for what indications they will allow that for each drug and if successful how long to actually get the drugs to patients.
Time to prepare a P3 and actually bring it to recruitment
Time to formulate a topical cream for B dermatology indications and then time to get a P2 going (or would we need a quick P1 for a cream).
Time remaining to bring K and B to oral formulations
Time to get oral formulations accepted so that P2 trials could begin with them
Exactly how impactful as to time the Fast Track designation will be to get B to Oral Mucositis patients and Kevetrin to retinoblastoma patients.
The next 45 days should give us a pretty good idea as to the value of P, but until we then get a deal of significant monetary upfront value we could then go into another quiet period until further items mentioned above come to completion and justify further PRs.
I am in the camp that a deal of some magnitude will come forth soon after P top line results and that IPIX monetary position will greatly improve to prevent the need for further stock dilution to pay for operational expenses. But I do believe there will be some delay on further progress as to trials just due to the normal administrative requirements from the FDA as to getting anything done, regardless of Fast Track designation. The stock price will be dependent on the market and I hope it finally wises up to recognize the value of IPIX and knock the socks off those that have been holding it down, though I realize a lot of the holding down has been the need to issue stock regularly over the last 8 months or more to pay for trial costs.
Guess I am just preparing myself to the possibility that we could get great news regarding P very soon (expecting it with a high degree of confidence) but the expected deal(s) soon (though nobody knows exactly when) may be the only real booster for the share price so that we may not see a robust uptick in the share price right away as I and so many others were expecting.
It will then go back to accepting that the science is moving forward and we may have a bit longer to wait for the market to value us at what we all know should be at a vastly higher price.
FDA to grant Expanded Access/Compassionate Use designation and exactly for what indications they will allow that for each drug and if successful how long to actually get the drugs to patients.
Time to prepare a P3 and actually bring it to recruitment
Time to formulate a topical cream for B dermatology indications and then time to get a P2 going (or would we need a quick P1 for a cream).
Time remaining to bring K and B to oral formulations
Time to get oral formulations accepted so that P2 trials could begin with them
Exactly how impactful as to time the Fast Track designation will be to get B to Oral Mucositis patients and Kevetrin to retinoblastoma patients.
The next 45 days should give us a pretty good idea as to the value of P, but until we then get a deal of significant monetary upfront value we could then go into another quiet period until further items mentioned above come to completion and justify further PRs.
I am in the camp that a deal of some magnitude will come forth soon after P top line results and that IPIX monetary position will greatly improve to prevent the need for further stock dilution to pay for operational expenses. But I do believe there will be some delay on further progress as to trials just due to the normal administrative requirements from the FDA as to getting anything done, regardless of Fast Track designation. The stock price will be dependent on the market and I hope it finally wises up to recognize the value of IPIX and knock the socks off those that have been holding it down, though I realize a lot of the holding down has been the need to issue stock regularly over the last 8 months or more to pay for trial costs.
Guess I am just preparing myself to the possibility that we could get great news regarding P very soon (expecting it with a high degree of confidence) but the expected deal(s) soon (though nobody knows exactly when) may be the only real booster for the share price so that we may not see a robust uptick in the share price right away as I and so many others were expecting.
It will then go back to accepting that the science is moving forward and we may have a bit longer to wait for the market to value us at what we all know should be at a vastly higher price.
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