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Thursday, August 27, 2015 3:18:20 AM
George Evans
*Failed to raise enough money for the start of a Phase 1 trial.
*Contracted with a drug maker that went bankrupt just after the CMC completed. The FDA refused to allow their Kevetrin be used for trials because it would need to be manufactured by a different maker if the phase 1 trial extended and patients required multiple cycles (it did and they did).
*The change of manufacturer caused some of the elements of the CMC be repeated, especially requiring new stabilization and packaging tests. This alone delayed the start of the trial 6 months.
*Ultimately the the start of the K trial delayed more than a year after the INDA was submitted, including the revision of the INDA.
*Tried to increase share price by a reverse split to raise more money.
*Couldn't find any takers for a PIPE or VCs, even at toxic financing terms.
*Caused development of all drugs to come to stop due to no funding.
*Caused the share price to collapse to 10 cents.
The right CEO:
Leo
*Loaned CTIX a total of $2 million of his own money to pay the new manufacturer and restart the IND process.
*Was able to increase the share price to 1.10 before correcting and consolidating at .35-.45.
*Current SP is still well above the highest valuation under Evans.
*Has sheparded 3 drugs into 5 trials with 2 more ready to start.
*Negotiated very favorable terms for $10s of millions of dollars with Aspire.
* Has successfully and consistently placed trials at clinical sites that are heavily subsidized by government, charity and private sources. These heavily subsidized trial sites include Harvard and University of Bologna.
*Has overseen a burn rate of well less than $10 million a year in a corporate sector of startups well known for burn rates in excess of $50 million a year.
*Successfully bought for $4 million an entire pipeline of drugs one of which will soon start Phase 3 and another already started Phase 2.
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